ConstipationPhase 3NCT00526097
Dulcolax vs Placebo in Functional Constipation
A Phase 3 study testing Bisacodyl 10 mg in people with Constipation, run by Boehringer Ingelheim at 27 sites in United Kingdom.
Trial summary
The objective of the study was to compare the efficacy and safety of 4 weeks treatment with bisacodyl (Dulcolax) tablets 10 mg to placebo in patients with functional constipation. In addition, the effect of treatment on quality of life and general health status was evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- Bisacodyl 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 368 participants
- Where
- 27 sitesUnited Kingdom
- Study dates
- Sep 2007to Jun 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients, aged 18 and above
- Suffering from functional constipation, according to their medical history, as defined by the Rome III diagnostic criteria , i.e.:Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
- Must include 2 or more of the following::
- straining during at least 25% of the defecations
- lumpy or hard stools in at least 25% of the defecations
- sensation of incomplete evacuation for at least 25% of the defecations
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- sensation of anorectal obstruction/blockade for at least 25% of the defecations
- manual manoeuvres to facilitate at least 25% of the defecations (e.g. digital evacuation, support of the pelvic floor)
- fewer than 3 defecations per week
- Loose stools are rarely present without the use of laxatives
- There are insufficient criteria for irritable bowel syndrome (IBS)
- Able and willing to complete a daily e-diary
- Able and willing to use the trial rescue medication
- Signed and dated written informed consent prior to enrolment into the study in accordance with GCP and local legislation
- At Visit 2, patients must comply with the following additional inclusion criteria to be eligible for entry into the treatment phase:
- Functional constipation is confirmed by e-diary data at the end of the baseline period:
- An average of less than 3 CSBMs per week, together with at least one of the following symptoms occurring at least 25% of the time:
- straining
- incomplete evacuation
- lumpy or hard stools (i.e. type 1 or type 2 stools)
- Compliant with the use of the e-diary throughout the baseline period (compliance is defined as completing 80% of the evening reports)
- Compliant with the use of rescue medication throughout the baseline period. Compliance is defined as follows:
- rescue medication may be used if there has not been a bowel movement for more than 72 hrs rescue medication may not be used on either day -1 or on the day of randomisation (day 1)
Who cannot join
- Eating disorders such as anorexia nervosa and bulimia, as a cause of excessive use of laxatives
- Patients whose constipation is caused by primary organic disease of the colon or pelvic floor
- Patients with metabolic disorders, neurological disorders, severe or psychiatric disorders, or any other significant disease or intercurrent illness (e.g. abdominal/gastrointestinal surgery) that, in the Investigators opinion, would interfere with participation in the trial
- Patients with restricted mobility (e.g. wheelchair bound, or bed-ridden) that, in the Investigators opinion, would interfere with participation in the trial
- Patients with a known hypersensitivity to bisacodyl or any other ingredient in the study medication
- Patients with ileus, intestinal obstruction, acute surgical abdominal conditions (such as acute appendicitis and acute inflammatory bowel diseases), or severe dehydration
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- Patients with anal fissures or ulcerative proctitis with mucosal damage
- Patients with known clinically significant abnormal electrolyte values
- Patients whose concomitant therapy includes an opioid medication (e.g. morphine, codeine)
- Constipation which, in the Investigators opinion, is caused by medication (e.g. anticholinergics)
- Patients who are not willing to discontinue the use of prohibited concomitant therapy
- Pre-menopausal women who:
- are nursing (breast-feeding) or who are pregnant OR
- who are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include:
- transdermal patch
- intra-uterine devices/systems (IUDs/IUSs)
- oral, implantable or injectable contraceptives
- sexual abstinence
- sterilisation or a vasectomised partner
- Participation in another trial with an investigational product with 1 month of enrolment into this study
- Drug or alcohol abuse
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United Kingdom27 sites
122.56.44032 Boehringer Ingelheim Investigational Site
Addlestone
122.56.44018 Boehringer Ingelheim Investigational Site
Ash Vale, Aldershot
122.56.44029 Boehringer Ingelheim Investigational Site
Ashford
122.56.44023 Boehringer Ingelheim Investigational Site
Atherstone
122.56.44011 Boehringer Ingelheim Investigational Site
Bedworth
122.56.44009 Boehringer Ingelheim Investigational Site
Bennetthorpe, Doncaster
122.56.44025 Boehringer Ingelheim Investigational Site
Bexhill-on-Sea
122.56.44012 Boehringer Ingelheim Investigational Site
Blackpool
122.56.44024 Boehringer Ingelheim Investigational Site
Burbage
122.56.44003 Boehringer Ingelheim Investigational Site
Cardiff
122.56.44017 Boehringer Ingelheim Investigational Site
Chesterfield
122.56.44014 Boehringer Ingelheim Investigational Site
Chippenham
122.56.44006 Boehringer Ingelheim Investigational Site
Chorley
122.56.44033 Boehringer Ingelheim Investigational Site
Dundee
122.56.44002 Boehringer Ingelheim Investigational Site
Edgbaston, Birmingham
122.56.44004 Boehringer Ingelheim Investigational Site
Glasgow
122.56.44007 Boehringer Ingelheim Investigational Site
Liverpool
122.56.44005 Boehringer Ingelheim Investigational Site
Manchester
122.56.44010 Boehringer Ingelheim Investigational Site
Midsomer Norton
122.56.44021 Boehringer Ingelheim Investigational Site
Newtonabbey
122.56.44022 Boehringer Ingelheim Investigational Site
Paignton
122.56.44020 Boehringer Ingelheim Investigational Site
Royal Leamington Spa
122.56.44001 Boehringer Ingelheim Investigational Site
Slough
122.56.44026 Boehringer Ingelheim Investigational Site
Sunbury-on-Thames
122.56.44019 Boehringer Ingelheim Investigational Site
Swindon
122.56.44015 Boehringer Ingelheim Investigational Site
Warminster
122.56.44008 Boehringer Ingelheim Investigational Site
Wolverhampton
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks Treatment With Bisacodyl (Dulcolax) Tablets 10mg Administered Orally, Once Daily, in Patients With Functional Constipation.
The objective of the study was to compare the efficacy and safety of 4 weeks treatment with bisacodyl (Dulcolax) tablets 10 mg to placebo in patients with functional constipation. In addition, the effect of treatment on quality of life and general health status was evaluated.
- Conditions
- Constipation
- Being tested
- Bisacodyl 10 mg, Placebo
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bisacodyl 10 mgDrug
2 x 5 mg bisacodyl once daily
PlaceboDrug
Placebo-to-match bisacodyl 10 mg (2 x 5 mg) once daily
| Study group | Role | What they receive |
|---|---|---|
| Bisacodyl 5 mg x 2 once daily | Experimental | patient to receive two enteric-coated tablets containing 5 mg bisacodyl Receives: Drug: Bisacodyl 10 mg |
| Placebo | Placebo comparator | patient to receive two placebo-to-match enteric-coated tablets 5 mg bisacodyl Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week Over the 4 Weeks Treatment Period
A Complete Spontaneous Bowel Movement (CSBM) is a complete non-rescue medication-induced stool.
The number of CSBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data.
Measured: 4 Weeks
Secondary outcomes (85)
Number of CSBMs at Week 1
The number of CSBMs at week 1 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Measured: Week 1 in treatment period
Number of CSBMs at Week 2
The number of CSBMs at week 2 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Measured: Week 2 in treatment period
Number of CSBMs at Week 3
The number of CSBMs at week 3 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Measured: Week 3 in treatment period
Number of CSBMs at Week 4
The number of CSBMs at week 4 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Measured: Week 4 in treatment period
Mean Number of SBMs Per Week Over the 4 Weeks Treatment Period
A Spontaneous Bowel Movement (SBM) is a non-rescue medication-induced stool. The number of SBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data.
Measured: 4 Weeks
Number of SBMs at Week 1
The number of SBMs at week 1 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Measured: Week 1 in treatment period
Number of SBMs at Week 2
The number of SBMs at week 2 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Measured: Week 2 in treatment period
Number of SBMs at Week 3
The number of SBMs at week 3 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Measured: Week 3 in treatment period
Number of SBMs at Week 4
The number of SBMs at week 4 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Measured: Week 4 in treatment period
Time to the First SBM Following the First Dose of Study Medication (SM)
The time to the first SBM following the first dose of SM was captured by the eDiary. The time was censored by the time of intake of rescue medication (RM), the time of premature discontinuation or the end of treatment whatever was minimal.
Measured: Time of first dose of SM up to 4 weeks
Number of Participants With an Increase of at Least 1 in the Mean Number of CSBMs Per Week Over the 4 Weeks Treatment Period Compared to Baseline
Measured: Baseline and 4 weeks
Number of Participants With an Increase of at Least 1 CSBM at Week 1 Compared to Baseline
Measured: Baseline and week 1 in treatment period
Number of Participants With an Increase of at Least 1 CSBM at Week 2 Compared to Baseline
Measured: Baseline and week 2 in treatment period
Number of Participants With an Increase of at Least 1 CSBM at Week 3 Compared to Baseline
Measured: Baseline and week 3 in treatment period
Number of Participants With an Increase of at Least 1 CSBM at Week 4 Compared to Baseline
Measured: Baseline and week 4 in treatment period
Number of Participants With a Mean of at Least 1 CSBM a Day Over the 4 Weeks Treatment Period
Measured: 4 weeks
Number of Participants With a Mean of at Least 3 CSBMs a Week Over the 4 Weeks Treatment Period
Measured: 4 weeks
Number of Premature Withdrawals Over the 4 Weeks Treatment Period
Measured: 4 weeks
Number of Premature Withdrawals at Week 1 in the Treatment Period
Measured: Week 1 in the treatment period
Number of Premature Withdrawals at Week 2 in the Treatment Period
Measured: Week 2 in the treatment period
Number of Premature Withdrawals at Week 3 in the Treatment Period
Measured: Week 3 in the treatment period
Number of Premature Withdrawals at Week 4 in the Treatment Period
Measured: Week 4 in the treatment period
Number of Participants Using Rescue Medication Over the 4 Weeks Treatment Period
Measured: 4 weeks
Number of Participants Using Rescue Medication at Week 1 in the Treatment Period
Measured: Week 1 in the treatment period
Number of Participants Using Rescue Medication at Week 2 in the Treatment Period
Measured: Week 2 in the treatment period
Number of Participants Using Rescue Medication at Week 3 in the Treatment Period
Measured: Week 3 in the treatment period
Number of Participants Using Rescue Medication at Week 4 in the Treatment Period
Measured: Week 4 in the treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 1
The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Measured: Baseline and week 1 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 2
The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Measured: Baseline and week 2 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 3
The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Measured: Baseline and week 3 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 4
The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Measured: Baseline and week 4 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 1
The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Measured: Baseline and week 1 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 2
The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Measured: Baseline and week 2 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 3
The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Measured: Baseline and week 3 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 4
The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Measured: Baseline and week 4 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 1
The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Measured: Baseline and week 1 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 2
The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Measured: Baseline and week 2 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 3
The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Measured: Baseline and week 3 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 4
The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Measured: Baseline and week 4 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 1
The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Measured: Baseline and week 1 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 2
The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Measured: Baseline and week 2 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 3
The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Measured: Baseline and week 3 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 4
The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Measured: Baseline and week 4 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 1
The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Measured: Baseline and week 1 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 2
The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Measured: Baseline and week 2 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 3
The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Measured: Baseline and week 3 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 4
The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Measured: Baseline and week 4 in treatment period
Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 1 in the Treatment Period in Comparison to Baseline
Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline
Measured: Baseline and week 1 in the treatment period
Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 2 in the Treatment Period in Comparison to Baseline
Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline
Measured: Baseline and week 2 in the treatment period
Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 3 in the Treatment Period in Comparison to Baseline
Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline
Measured: Baseline and week 3 in the treatment period
Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 4 in the Treatment Period in Comparison to Baseline
Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline
Measured: Baseline and week 4 in the treatment period
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 1 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Measured: Baseline and week 1 in the treatment period
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 2 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Measured: Baseline and week 2 in the treatment period
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 3 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Measured: Baseline and week 3 in the treatment period
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 4 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Measured: Baseline and week 4 in the treatment period
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 1 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Measured: Baseline and week 1 in the treatment period
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 2 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Measured: Baseline and week 2 in the treatment period
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 3 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Measured: Baseline and week 3 in the treatment period
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 4 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Measured: Baseline and week 4 in the treatment period
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 1 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Measured: Baseline and week 1 in the treatment period
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 2 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Measured: Baseline and week 2 in the treatment period
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 3 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Measured: Baseline and week 3 in the treatment period
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 4 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Measured: Baseline and week 4 in the treatment period
Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator
Final global assessment scale range: 1 (good) to 4 (bad), ordinal
Measured: 4 weeks
Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient
Final global assessment scale range: 1 (good) to 4 (bad), ordinal
Measured: 4 weeks
Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator
Final global assessment scale range: 1 (good) to 4 (bad), ordinal
Measured: 4 weeks
Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient
Final global assessment scale range: 1 (good) to 4 (bad), ordinal
Measured: 4 weeks
Change From Baseline in the SF-36 Dimension 'Physical Functioning'
The dimension is a sum of 10 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Measured: Baseline and 4 weeks
Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Physical Problems'
The dimension is a sum of 4 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Measured: Baseline and 4 weeks
Change From Baseline in the SF-36 Dimension 'Bodily Pain'
The dimension is a sum of 2 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Measured: Baseline and 4 weeks
Change From Baseline in the SF-36 Dimension 'General Health'
The dimension is a sum of 5 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Measured: Baseline and 4 weeks
Change From Baseline in the SF-36 Dimension 'Vitality'
The dimension is a sum of 4 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Measured: Baseline and 4 weeks
Change From Baseline in the SF-36 Dimension 'Social Functioning'
The dimension is a sum of 2 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Measured: Baseline and 4 weeks
Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Emotional Problems'
The dimension is a sum of 3 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Measured: Baseline and 4 weeks
Change From Baseline in the SF-36 Dimension 'Mental Health'
The dimension is a sum of 5 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Measured: Baseline and 4 weeks
Change From Baseline in the SF-36 Mental Component Scale (MCS)
The MCS is a summary scale of the dimensions vitality, social functioning, role-emotional, and mental health. The component scale is norm-based to a standard population. A higher score indicates a better health.
Measured: Baseline and 4 weeks
Change From Baseline in the SF-36 Physical Component Scale (PCS)
The PCS is a summary scale of the subscales physical functioning, role-physical, bodily pain, and general health. The component scale is norm-based to a standard population. A higher score indicates a better health.
Measured: Baseline and 4 weeks
Change From Baseline in the PAC-QoL Subscale 'Worries and Concerns'
The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL
Measured: Baseline and 4 weeks
Change From Baseline in the PAC-QoL Subscale 'Physical Discomfort'
The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL
Measured: Baseline and 4 weeks
Change From Baseline in the PAC-QoL Subscale 'Psychosocial Discomfort'
The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL
Measured: Baseline and 4 weeks
Change From Baseline in the PAC-QoL Subscale 'Satisfaction'
The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL
Measured: Baseline and 4 weeks
Change From Baseline in the PAC-QoL Overall Score
The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL
Measured: Baseline and 4 weeks
Change From Baseline for Sodium (Normalized Value)
Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range
Measured: Baseline and 4 weeks
Change From Baseline for Potassium (Normalized Value)
Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range
Measured: Baseline and 4 weeks
Change From Baseline for Chloride (Normalized Value)
Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526097
- Sponsor's protocol ID
- 122.56
- Other IDs
- EUDRACT 2007-001991-34
- Status last verified
- Dec 2013
- First submitted
- 5 Sep 2007
- Last updated
- 15 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks Treatment With Bisacodyl (Dulcolax) Tablets 10mg Administered Orally, Once Daily, in Patients With Functional Constipation.
- ClinicalTrials.gov ID
- NCT00526097
- Acronym / sponsor ID
- 122.56
- Conditions
- Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Jun 2009 (actual)
- First posted
- 6 Sep 2007 (estimated)
- Results
- Posted 6 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study was to compare the efficacy and safety of 4 weeks treatment with bisacodyl (Dulcolax) tablets 10 mg to placebo in patients with functional constipation. In addition, the effect of treatment on quality of life and general health status was evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bisacodyl 5 mg x 2 once daily | Experimental | Drug: Bisacodyl 10 mgpatient to receive two enteric-coated tablets containing 5 mg bisacodyl |
| Placebo | Placebo comparator | Drug: Placebopatient to receive two placebo-to-match enteric-coated tablets 5 mg bisacodyl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Male and female patients, aged 18 and above
- Suffering from functional constipation, according to their medical history, as defined by the Rome III diagnostic criteria , i.e.:Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
- Able and willing to complete a daily e-diary
- Able and willing to use the trial rescue medication
- Signed and dated written informed consent prior to enrolment into the study in accordance with GCP and local legislation
Key exclusion criteria (21 listed)
- Eating disorders such as anorexia nervosa and bulimia, as a cause of excessive use of laxatives
- Patients whose constipation is caused by primary organic disease of the colon or pelvic floor
- Patients with metabolic disorders, neurological disorders, severe or psychiatric disorders, or any other significant disease or intercurrent illness (e.g. abdominal/gastrointestinal surgery) that, in the Investigators opinion, would interfere with participation in the trial
- Patients with restricted mobility (e.g. wheelchair bound, or bed-ridden) that, in the Investigators opinion, would interfere with participation in the trial
- Patients with a known hypersensitivity to bisacodyl or any other ingredient in the study medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bisacodyl 10 mg2 x 5 mg bisacodyl once daily | Drug | Bisacodyl 5 mg x 2 once daily |
| PlaceboPlacebo-to-match bisacodyl 10 mg (2 x 5 mg) once daily | Drug | Placebo |
Primary outcome
Mean Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week Over the 4 Weeks Treatment Period
Time frame: 4 Weeks
A Complete Spontaneous Bowel Movement (CSBM) is a complete non-rescue medication-induced stool. The number of CSBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data.
85 secondary outcomes
Number of CSBMs at Week 1
Time frame: Week 1 in treatment period
Number of CSBMs at Week 2
Time frame: Week 2 in treatment period
Number of CSBMs at Week 3
Time frame: Week 3 in treatment period
Number of CSBMs at Week 4
Time frame: Week 4 in treatment period
Mean Number of SBMs Per Week Over the 4 Weeks Treatment Period
Time frame: 4 Weeks
Number of SBMs at Week 1
Time frame: Week 1 in treatment period
Number of SBMs at Week 2
Time frame: Week 2 in treatment period
Number of SBMs at Week 3
Time frame: Week 3 in treatment period
Number of SBMs at Week 4
Time frame: Week 4 in treatment period
Time to the First SBM Following the First Dose of Study Medication (SM)
Time frame: Time of first dose of SM up to 4 weeks
Number of Participants With an Increase of at Least 1 in the Mean Number of CSBMs Per Week Over the 4 Weeks Treatment Period Compared to Baseline
Time frame: Baseline and 4 weeks
Number of Participants With an Increase of at Least 1 CSBM at Week 1 Compared to Baseline
Time frame: Baseline and week 1 in treatment period
Number of Participants With an Increase of at Least 1 CSBM at Week 2 Compared to Baseline
Time frame: Baseline and week 2 in treatment period
Number of Participants With an Increase of at Least 1 CSBM at Week 3 Compared to Baseline
Time frame: Baseline and week 3 in treatment period
Number of Participants With an Increase of at Least 1 CSBM at Week 4 Compared to Baseline
Time frame: Baseline and week 4 in treatment period
Number of Participants With a Mean of at Least 1 CSBM a Day Over the 4 Weeks Treatment Period
Time frame: 4 weeks
Number of Participants With a Mean of at Least 3 CSBMs a Week Over the 4 Weeks Treatment Period
Time frame: 4 weeks
Number of Premature Withdrawals Over the 4 Weeks Treatment Period
Time frame: 4 weeks
Number of Premature Withdrawals at Week 1 in the Treatment Period
Time frame: Week 1 in the treatment period
Number of Premature Withdrawals at Week 2 in the Treatment Period
Time frame: Week 2 in the treatment period
Number of Premature Withdrawals at Week 3 in the Treatment Period
Time frame: Week 3 in the treatment period
Number of Premature Withdrawals at Week 4 in the Treatment Period
Time frame: Week 4 in the treatment period
Number of Participants Using Rescue Medication Over the 4 Weeks Treatment Period
Time frame: 4 weeks
Number of Participants Using Rescue Medication at Week 1 in the Treatment Period
Time frame: Week 1 in the treatment period
Number of Participants Using Rescue Medication at Week 2 in the Treatment Period
Time frame: Week 2 in the treatment period
Number of Participants Using Rescue Medication at Week 3 in the Treatment Period
Time frame: Week 3 in the treatment period
Number of Participants Using Rescue Medication at Week 4 in the Treatment Period
Time frame: Week 4 in the treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 1
Time frame: Baseline and week 1 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 2
Time frame: Baseline and week 2 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 3
Time frame: Baseline and week 3 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 4
Time frame: Baseline and week 4 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 1
Time frame: Baseline and week 1 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 2
Time frame: Baseline and week 2 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 3
Time frame: Baseline and week 3 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 4
Time frame: Baseline and week 4 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 1
Time frame: Baseline and week 1 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 2
Time frame: Baseline and week 2 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 3
Time frame: Baseline and week 3 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 4
Time frame: Baseline and week 4 in treatment period
Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 1
Time frame: Baseline and week 1 in treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bisacodyl 10 mg in people with Constipation, run by Boehringer Ingelheim at 27 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week Over the 4 Weeks Treatment Period (time frame: 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2014.