Irritable Bowel SyndromePhase 3NCT00399542
Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation
A Phase 3 study testing Lubiprostone in people with Irritable Bowel Syndrome and Constipation, run by Sucampo Pharma Americas, LLC.
Trial summary
The primary purpose of this study is to evaluate the efficacy and safety of administration of lubiprostone in patients with irritable bowel syndrome with constipation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome, Constipation
- What is being tested?
- Lubiprostone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 581 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Jul 2006
- 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
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- Stable fiber therapy
- Normal colonoscopy/sigmoidoscopy
- Able to refrain from use of medications known to treat or associated with constipation symptoms
- Experiences abdominal discomfort/pain associated with bowel movements
- Reports decreased bowel movement frequency and/or other symptoms associated with constipation
Who cannot join
- Diarrhea-predominant or alternating (diarrhea \& constipation cycling) IBS, or constipation other than that associated with IBS
- Open gastrointestinal or abdominal surgery prior to IBS onset
- Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, unexplained weight loss or rectal bleeding
- Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests per investigator discretion
- If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study
About this study
Official title: Phase 3, 12-Week, Multicenter, Double-Blind, Randomized, Efficacy and Safety Study of Lubiprostone for the Treatment of Irritable Bowel Syndrome With Constipation
The primary purpose of this study is to evaluate the efficacy and safety of administration of lubiprostone in patients with irritable bowel syndrome with constipation.
- Conditions
- Irritable Bowel Syndrome, Constipation
- Being tested
- Lubiprostone, Placebo
- Keywords
- Irritable Bowel Syndrome With Constipation
- Medical subject headings
- Irritable Bowel Syndrome, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LubiprostoneDrug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Responder Status
Overall responder: monthly responder for at least 2 out of 3 months
Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:
Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.
Measured: 12 weeks
Secondary outcomes (28)
Month 1 Spontaneous Bowel Movement Rates Change From Baseline
Any bowel movement not associated with rescue medication use
Measured: 28 days
Month 1 Stool Consistency Change From Baseline
0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
Measured: 28 days
Month 1 Bowel Straining Change From Baseline
0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: 28 days
Month 1 Constipation Severity Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: 28 days
Month 1 Symptom Relief
- 3 = Significantly worse, -2 = Moderately worse,
- 1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved
Measured: 28 days
Month 1 Responder Rate
Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:
Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.
Measured: 28 days
Month 2 Responder Rate
Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:
Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.
Measured: 28 days
Month 3 Responder Rate
Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:
Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.
Measured: 28 days
Month 1 Abdominal Pain Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: 28 days
Month 2 Abdominal Pain Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: 28 days
Month 3 Abdominal Pain Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: 28 days
Month 1 Abdominal Bloating Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: 28 days
Month 2 Abdominal Bloating Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: 28 days
Month 3 Abdominal Bloating Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: 28 days
Month 2 Spontaneous Bowel Movement Rates Change From Baseline
Any bowel movement not associated with rescue medication use
Measured: 28 days
Month 3 Spontaneous Bowel Movement Rates Change From Baseline
Any bowel movement not associated with rescue medication use
Measured: 28 days
Month 2 Stool Consistency Change From Baseline
0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
Measured: 28 days
Month 3 Stool Consistency Change From Baseline
0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
Measured: 28 days
Month 2 Bowel Straining Change From Baseline
0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: 28 days
Month 3 Bowel Straining Change From Baseline
0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: 28 days
Month 2 Constipation Severity Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: 28 days
Month 3 Constipation Severity Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Measured: 28 days
Month 2 Symptom Relief
- 3 = Significantly worse, -2 = Moderately worse,
- 1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved
Measured: 28 days
Month 3 Symptom Relief
- 3 = Significantly worse, -2 = Moderately worse,
- 1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved
Measured: 28 days
Month 3 Quality of Life Change From Baseline
IBS-QOL questionnaire included 34 questions with 5 possible responses yielding the following sub-categories: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship Results range from 34 (low) to 100 (high); meaningful clinical improvement=14 point increase
Measured: 12 weeks
Month 1 Bowel Movement Rates Change From Baseline
Measured: 28 days
Month 2 Bowel Movement Rates Change From Baseline
Measured: 28 days
Month 3 Bowel Movement Rates Change From Baseline
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2006 (estimated)
- Study startMay 2005
- Primary completionJul 2006
- Study completionJul 2006
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 Irritable Bowel SyndromeStudies of the same condition, open and under way.
- 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
- 581 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sucampo Pharma Americas, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sucampo Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, MD, Study director, Sucampo Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399542
- Sponsor's protocol ID
- 0211SIB-0432
- Status last verified
- Sep 2013
- First submitted
- 13 Nov 2006
- Last updated
- 17 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, 12-Week, Multicenter, Double-Blind, Randomized, Efficacy and Safety Study of Lubiprostone for the Treatment of Irritable Bowel Syndrome With Constipation
- ClinicalTrials.gov ID
- NCT00399542
- Acronym / sponsor ID
- 0211SIB-0432
- Conditions
- Irritable Bowel Syndrome, Constipation
- Keywords
- Irritable Bowel Syndrome With Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 581 participants (actual)
- Lead sponsor
- Sucampo Pharma Americas, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Sucampo Pharmaceuticals, Inc.
- Study start
- May 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 15 Nov 2006 (estimated)
- Results
- Posted 31 Oct 2008
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the efficacy and safety of administration of lubiprostone in patients with irritable bowel syndrome with constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age and older
- Stable fiber therapy
- Normal colonoscopy/sigmoidoscopy
- Able to refrain from use of medications known to treat or associated with constipation symptoms
- Experiences abdominal discomfort/pain associated with bowel movements
Key exclusion criteria (5 listed)
- Diarrhea-predominant or alternating (diarrhea \& constipation cycling) IBS, or constipation other than that associated with IBS
- Open gastrointestinal or abdominal surgery prior to IBS onset
- Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, unexplained weight loss or rectal bleeding
- Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests per investigator discretion
- If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study
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 |
|---|---|---|
| Lubiprostone | Drug | – |
| Placebo | Drug | – |
Primary outcome
Overall Responder Status
Time frame: 12 weeks
Overall responder: monthly responder for at least 2 out of 3 months Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF: Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.
28 secondary outcomes
Month 1 Spontaneous Bowel Movement Rates Change From Baseline
Time frame: 28 days
Month 1 Stool Consistency Change From Baseline
Time frame: 28 days
Month 1 Bowel Straining Change From Baseline
Time frame: 28 days
Month 1 Constipation Severity Change From Baseline
Time frame: 28 days
Month 1 Symptom Relief
Time frame: 28 days
Month 1 Responder Rate
Time frame: 28 days
Month 2 Responder Rate
Time frame: 28 days
Month 3 Responder Rate
Time frame: 28 days
Month 1 Abdominal Pain Change From Baseline
Time frame: 28 days
Month 2 Abdominal Pain Change From Baseline
Time frame: 28 days
Month 3 Abdominal Pain Change From Baseline
Time frame: 28 days
Month 1 Abdominal Bloating Change From Baseline
Time frame: 28 days
Month 2 Abdominal Bloating Change From Baseline
Time frame: 28 days
Month 3 Abdominal Bloating Change From Baseline
Time frame: 28 days
Month 2 Spontaneous Bowel Movement Rates Change From Baseline
Time frame: 28 days
Month 3 Spontaneous Bowel Movement Rates Change From Baseline
Time frame: 28 days
Month 2 Stool Consistency Change From Baseline
Time frame: 28 days
Month 3 Stool Consistency Change From Baseline
Time frame: 28 days
Month 2 Bowel Straining Change From Baseline
Time frame: 28 days
Month 3 Bowel Straining Change From Baseline
Time frame: 28 days
Month 2 Constipation Severity Change From Baseline
Time frame: 28 days
Month 3 Constipation Severity Change From Baseline
Time frame: 28 days
Month 2 Symptom Relief
Time frame: 28 days
Month 3 Symptom Relief
Time frame: 28 days
Month 3 Quality of Life Change From Baseline
Time frame: 12 weeks
Month 1 Bowel Movement Rates Change From Baseline
Time frame: 28 days
Month 2 Bowel Movement Rates Change From Baseline
Time frame: 28 days
Month 3 Bowel Movement Rates Change From Baseline
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Monitor, MD study director
Sucampo Pharmaceuticals, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lubiprostone in people with Irritable Bowel Syndrome and Constipation, run by Sucampo Pharma Americas, LLC.
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 6 inclusion and 5 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 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 31 Oct 2008). 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?
Overall Responder Status (time frame: 12 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 17 Dec 2019.