ConstipationPhase 2NCT01212445
Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation (Protocol P07515)
A Phase 2 study testing PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430) in people with Constipation, run by Bayer at 1 site in Ireland.
Trial summary
The primary objective of the study was to evaluate the proportion of subjects with a bowel movement (BM) without straining or without hard and/or lumpy stool within the first 24 h of treatment for subjects taking 1 of 3 single doses of Polyethylene Glycol (PEG) plus Electrolytes (PEG+E) (13.125 g, 26.25 g, 39.375 g). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteIreland
- Study dates
- Oct 2010to Nov 2011
- Phase
- Phase 2
- 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
- A willingness to participate in the study and comply with its procedures
- Must be ambulatory
- Male or female subjects aged 18 years or older who met two or more of the following modified Rome III-based criteria for constipation: (a) straining during at least 25% of defecations; (b) lumpy or hard stools in at least 25% of defecations; (c) sensation of incomplete evacuation for at least 25% of defecation; (d) sensation of anorectal obstruction/blockage for at least 25% of defecations; (e) manual maneuvers to facilitate at least 25% of defecations (eg, digital evacuation, support of the pelvic floor), and (f) fewer than 3 defecations per week
- Criteria fulfilled for the last 3 months with symptom onset at least 6 mo prior to diagnosis
- Had a self reported or documented history of chronic constipation
- Agreed not to use laxatives other than the study treatment from baseline/informed consent to end-of-study
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- Agreed to maintain a similar diet from the week before Visit 3 to the end-of-study were to be enrolled
- Additionally required not to use any treatment known to cause constipation during the study (for subjects enrolled after Amendment 1)
- If a female subject, either surgically sterile, 2 years postmenopausal, or using an acceptable method of contraception. Abstinence was not an acceptable method of contraception. Females of childbearing potential had to have a urine pregnancy test (human chorionic gonadotropin [HCG]) that was negative at Visit 3
- Be able to read and write in the diaries in English
Who cannot join
- Had loose stools without the use of laxatives
- Recurrent abdominal pain
- Known or suspected bowel perforation, obstruction, or fecal impaction; or had gastric retention, inflammatory bowel disease, bowel resection, or colostomy
- Celiac disease or known gluten sensitivity
- Known renal or hepatic insufficiency
- Recent history of alcohol abuse or drug abuse
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- History of psychiatric disorders
- History of significant ongoing medical problems or scheduled for surgical procedures
- Subjects who, in the opinion of the Investigator, should not have been included in the study for any reason, including inability to follow study procedures
- Participated in an investigational clinical, surgical, drug or device study within the past 30 days
- Pregnant or lactating
- Allergic to PEG or PEG+E
- Employed by or have immediate family members employed by a company that manufactures laxative products
- Participant or family member of the Investigator or site staff directly involved with this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation
The primary objective of the study was to evaluate the proportion of subjects with a bowel movement (BM) without straining or without hard and/or lumpy stool within the first 24 h of treatment for subjects taking 1 of 3 single doses of Polyethylene Glycol (PEG) plus Electrolytes (PEG+E) (13.125 g, 26.25 g, 39.375 g). The doses specified relate to the doses of PEG. Secondary objectives were measured by analysis of a subject diary and self-reported BM data. The secondary objectives included comparisons of PEG+E doses at 24 h for: BM control; relief of gas; relief of bloating; and relief of abdominal discomfort/cramping.
In addition, the proportion of subjects with a BM (without straining and without hard and/or lumpy stool) within the first 24 h of treatment for subjects taking different doses of PEG+E was evaluated for the time to first BM.
- Conditions
- Constipation
- Being tested
- PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)Drug
13.125 g of PEG 3350 powder with approximately 0.6 g of electrolytes
| Study group | Role | What they receive |
|---|---|---|
| PEG + E, 13.125 g | Experimental | Single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time Receives: Drug: PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430) |
| PEG + E, 26.25 g | Experimental | Two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time Receives: Drug: PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430) |
| PEG + E, 39.375 g | Experimental | Three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time Receives: Drug: PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration
A successful BM was defined as a BM with no straining or hard/lumpy stools.
Measured: From time of study drug treatment up to 24 hours
Secondary outcomes (7)
Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration
Time to first successful bowel movement was defined as the duration (in days) from the time of first study dose of study treatment until first successful BM (defined as BM without straining and without hard and/or lumpy stool).
Measured: From time of study drug administration up to 3 Days
Percentage of Participants With Successful BM Within 12 Hours of PEG+E Administration
A successful BM was defined as a BM with no straining or hard/lumpy stools.
Measured: From time of study drug treatment up to 12 hours
Mean Visual Analog Scale (VAS) Rating for BM Control
The VAS is a psychometric response scale which measures responses along a continuum of values. The BM control VAS uses a 100 mm horizontal line with the two ends representing the opposite, extreme limits of the participant's experience of BM control. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. BM Control ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=Calm, not urgent and 100 mm= Not able to hold BM, very urgent.
Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group
Measured: From time of study drug treatment up to 24 hours
Mean VAS Rating for Gas
The VAS is a psychometric response scale which measures responses along a continuum of values. The Gas VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related gas. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Gas ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Severe.
Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group.
Measured: From time of study drug treatment up to 24 hours
Mean VAS Rating for Bloating
The VAS is a psychometric response scale which measures responses along a continuum of values. The Bloating VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related bloating. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Bloating ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Severe.
Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group.
Measured: From time of study drug treatment up to 24 hours
Mean VAS Rating for Abdominal Discomfort/Cramping
The VAS is a psychometric response scale which measures responses along a continuum of values. The Abdominal Discomfort/Cramping VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related abdominal discomfort/cramping. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Abdominal discomfort/cramping ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Painful.
Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group.
Measured: From time of study drug treatment up to 24 hours
Mean Participant Global Assessment of Treatment
At the End of Study Visit, the study staff asked the participant to rate their global assessment of the study treatment according to the following categories: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective.
Measured: From time of study drug administration up to 2 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2011
- Study completionNov 2011
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 BayerThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212445
- Sponsor's protocol ID
- 18129
- Other IDs
- 2010-021367-32
- Status last verified
- Feb 2016
- First submitted
- 29 Sep 2010
- Last updated
- 15 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation
- ClinicalTrials.gov ID
- NCT01212445
- Acronym / sponsor ID
- 18129
- Conditions
- Constipation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 30 Sep 2010 (estimated)
- Results
- Posted 11 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study was to evaluate the proportion of subjects with a bowel movement (BM) without straining or without hard and/or lumpy stool within the first 24 h of treatment for subjects taking 1 of 3 single doses of Polyethylene Glycol (PEG) plus Electrolytes (PEG+E) (13.125 g, 26.25 g, 39.375 g). The doses specified relate to the doses of PEG. Secondary objectives were measured by analysis of a subject diary and self-reported BM data. The secondary objectives included comparisons of PEG+E doses at 24 h for: BM control; relief of gas; relief of bloating; and relief of abdominal discomfort/cramping.
In addition, the proportion of subjects with a BM (without straining and without hard and/or lumpy stool) within the first 24 h of treatment for subjects taking different doses of PEG+E was evaluated for the time to first BM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PEG + E, 13.125 g | Experimental | Drug: PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)Single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time |
| PEG + E, 26.25 g | Experimental | Drug: PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)Two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time |
| PEG + E, 39.375 g | Experimental | Drug: PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)Three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- A willingness to participate in the study and comply with its procedures
- Must be ambulatory
- Male or female subjects aged 18 years or older who met two or more of the following modified Rome III-based criteria for constipation: (a) straining during at least 25% of defecations; (b) lumpy or hard stools in at least 25% of defecations; (c) sensation of incomplete evacuation for at least 25% of defecation; (d) sensation of anorectal obstruction/blockage for at least 25% of defecations; (e) manual maneuvers to facilitate at least 25% of defecations (eg, digital evacuation, support of the pelvic floor), and (f) fewer than 3 defecations per week
- Criteria fulfilled for the last 3 months with symptom onset at least 6 mo prior to diagnosis
- Had a self reported or documented history of chronic constipation
Key exclusion criteria (14 listed)
- Had loose stools without the use of laxatives
- Recurrent abdominal pain
- Known or suspected bowel perforation, obstruction, or fecal impaction; or had gastric retention, inflammatory bowel disease, bowel resection, or colostomy
- Celiac disease or known gluten sensitivity
- Known renal or hepatic insufficiency
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 |
|---|---|---|
| PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)13.125 g of PEG 3350 powder with approximately 0.6 g of electrolytes | Drug | PEG + E, 13.125 g, PEG + E, 26.25 g, PEG + E, 39.375 g |
Primary outcome
Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration
Time frame: From time of study drug treatment up to 24 hours
A successful BM was defined as a BM with no straining or hard/lumpy stools.
7 secondary outcomes
Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration
Time frame: From time of study drug administration up to 3 Days
Percentage of Participants With Successful BM Within 12 Hours of PEG+E Administration
Time frame: From time of study drug treatment up to 12 hours
Mean Visual Analog Scale (VAS) Rating for BM Control
Time frame: From time of study drug treatment up to 24 hours
Mean VAS Rating for Gas
Time frame: From time of study drug treatment up to 24 hours
Mean VAS Rating for Bloating
Time frame: From time of study drug treatment up to 24 hours
Mean VAS Rating for Abdominal Discomfort/Cramping
Time frame: From time of study drug treatment up to 24 hours
Mean Participant Global Assessment of Treatment
Time frame: From time of study drug administration up to 2 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link 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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430) in people with Constipation, run by Bayer at 1 site in Ireland.
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 10 inclusion and 14 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 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 11 Mar 2013). 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?
Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration (time frame: From time of study drug treatment up to 24 hours). 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 Mar 2016.