Constipation-Predominant Irritable Bowel SyndromePhase 3NCT00742872
Randomized Trial of Mosapride Versus Placebo in the Treatment of Constipation-Predominant Irritable Bowel Syndrome
A Phase 3 study testing Mosapride Citrate in people with Constipation-Predominant Irritable Bowel Syndrome, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
The purpose of this study is to determine whether Mosapride, an agent which acts on serotonin receptors in the gastrointestinal tract, is effective in the treatment of constipation-predominant irritable bowel syndrome (C-IBS). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Constipation-Predominant Irritable Bowel Syndrome
- What is being tested?
- Mosapride Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteLebanon
- Study dates
- Sep 2008to Jun 2010
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rome III Criteria for IBS:
- Patients must have recurrent abdominal pain or discomfort at least 3 days per month during the previous 3 months that is associated with 2 or more of the following:
- Relieved by defecation
- Onset associated with a change in stool frequency
- Onset associated with a change in stool form or appearance
- In addition, patients have to experience at least two of the following symptoms for at least 25% of the time [11]:
Show all 10Show fewer
- Altered stool frequency (< 3 bowel movements per week)
- Altered stool form (lumpy/hard i.e. Bristol type I-III [see appendix 1])
- Altered stool passage (straining, urgency, or a feeling of incomplete evacuation)
- Passage of mucus, bloating, or a feeling of abdominal distension
Who cannot join
- Previous allergy to mosapride
- Nocturnal Symptoms (pain in the middle of the night, or other nocturnal symptoms which suggest an organic disease)
- Age < 18 years
- History of bloody stools or melena
- Diarrhea (>3 bowel movements per day)
- Constitutional symptoms (fever, weight loss)
Show all 14Show fewer
- Severe constipation (< 1 bm/week)
- Pregnancy or lactation
- Patients with history of cardiac arrhythmias
- QT prolongation on baseline ECG
- Chronic laxative use and dependence
- Patients with previous history of congenital heart disease
- Patients with previous history of hypokalemia or hyperkalemia
- Patients taking the following classes of drugs: HIV antivirals, macrolides, anti-arrhythmics, and azole drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Double-Blind Placebo-Controlled Trial of Mosapride in Patients With Constipation-Predominant Irritable Bowel Syndrome
The purpose of this study is to determine whether Mosapride, an agent which acts on serotonin receptors in the gastrointestinal tract, is effective in the treatment of constipation-predominant irritable bowel syndrome (C-IBS).
- Being tested
- Mosapride Citrate, Placebo
- Keywords
- Mosapride, Irritable Bowel Syndrome, 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.
Mosapride CitrateDrug
Also called Mosar
One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks.
PlaceboDrug
One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Mosapride Receives: Drug: Mosapride Citrate |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome.
Measured: Within the first 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Poor recruitment, high drop out rate
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 Constipation-Predominant 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabil Mansour, American University of Beirut Medical Center
- Investigators
- Ala' I. Sharara, MD, Principal investigator, American University of Beirut Medical CenterNabil M. Mansour, MD, Study director, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742872
- Sponsor's protocol ID
- AUB-IM.AS1.21
- Status last verified
- Feb 2013
- First submitted
- 27 Aug 2008
- Last updated
- 9 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Double-Blind Placebo-Controlled Trial of Mosapride in Patients With Constipation-Predominant Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00742872
- Acronym / sponsor ID
- AUB-IM.AS1.21
- Keywords
- Mosapride, Irritable Bowel Syndrome, Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment, high drop out rate
- Enrolment
- 41 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 28 Aug 2008 (estimated)
- Results
- Posted 9 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Mosapride, an agent which acts on serotonin receptors in the gastrointestinal tract, is effective in the treatment of constipation-predominant irritable bowel syndrome (C-IBS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Mosapride CitrateMosapride |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Rome III Criteria for IBS:
- Patients must have recurrent abdominal pain or discomfort at least 3 days per month during the previous 3 months that is associated with 2 or more of the following:
- Relieved by defecation
- Onset associated with a change in stool frequency
- Onset associated with a change in stool form or appearance
Key exclusion criteria (14 listed)
- Previous allergy to mosapride
- Nocturnal Symptoms (pain in the middle of the night, or other nocturnal symptoms which suggest an organic disease)
- Age < 18 years
- History of bloody stools or melena
- Diarrhea (>3 bowel movements per day)
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 |
|---|---|---|
| Mosapride CitrateAlso: MosarOne 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks. | Drug | 1 |
| PlaceboOne tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks. | Drug | 2 |
Primary outcome
Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome.
Time frame: Within the first 8 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Constipation-Predominant Irritable Bowel Syndrome
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease
RecruitingObservational study
Single-center Exploratory Study of the Intestinal Microbiota in Patients Treated for Irritable Bowel Syndrome With Predominant Constipation and Methane Production
Irritable Bowel Syndrome
Not yet recruitingPhase 4
"Efficacy and Safety of Linaclotide in Chronic Constipation"
Chronic Idiopathic Constipation, Irritable Bowel Syndrome (IBS-C)
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.
Ala' I. Sharara, MD principal investigator
American University of Beirut Medical Center
Nabil M. Mansour, MD study director
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mosapride Citrate in people with Constipation-Predominant Irritable Bowel Syndrome, run by American University of Beirut Medical Center at 1 site in Lebanon.
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: stopped early, as of the sponsor's last update on 9 Apr 2013. 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 Lebanon. 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 9 Apr 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?
Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome. (time frame: Within the first 8 weeks of treatment). 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 9 Apr 2013.