Constipation-Predominant Irritable Bowel Syndrome
Conditions
Keywords
Mosapride, Irritable Bowel Syndrome, Constipation
Brief 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).
Interventions
One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks.
DRUGPlacebo
One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks.
Sponsors
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 \[11\]: * 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
Exclusion criteria
* 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) * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome. | Within the first 8 weeks of treatment |
Countries
Lebanon
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Mosapride
Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks. | 21 |
| Placebo Placebo
Placebo : One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks. | 20 |
| Total | 41 |
Baseline characteristics
| Characteristic | Study | Placebo | Total |
|---|---|---|---|
| Age Continuous | 44 years STANDARD_DEVIATION 17 | 41 years STANDARD_DEVIATION 16 | 43 years STANDARD_DEVIATION 16.5 |
| Region of Enrollment Lebanon | 21 participants | 20 participants | 41 participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 |
Outcome results
Primary
Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome.
Time frame: Within the first 8 weeks of treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study | Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome. | 7 participants |
| Placebo | Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome. | 10 participants |