Rifamycin SV-MMX® 600 mg Tablets Administered Three or Two Times Daily to Patients With IBS-D (NCT03099785) | Clinical Trial Compass
CompletedPhase 2
Rifamycin SV-MMX® 600 mg Tablets Administered Three or Two Times Daily to Patients With IBS-D
Belgium279 participantsStarted 2017-12-18
Plain-language summary
The objective of this study is to evaluate the safety and efficacy Rifamycin SV-MMX® 600 mg tablets for patients with diarrhoea-predominant irritable bowel syndrome when administered two to three times daily.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Informed Consent: signed written informed consent before inclusion in the study
✓. Sex and Age: males/females, ≥18 year old
✓. IBS Diagnosis: confirmed IBS-D diagnosis per Rome IV criteria
✓. Symptoms: active symptoms of IBS at baseline (day 1) as measured by average daily scores for at least 7 days before baseline:
✓. abdominal pain score ≥3 using an 11-point numeric rating scale and
✓. bloating score: 2-4 inclusive and
✓. stool consistency: score 6 or 7 (measured by the Bristol stool form scale) for at least 2 days from day -7 to day -1
✓. "In the past 7 days, have you had adequate relief of your IBS symptoms?" \[No\] and
Exclusion criteria
✕. IBS: symptoms of constipation at baseline:
✕. less than 3 bowel movements a week and
✕. stool consistency score ≤2 for ≥2 days in a week
✕. Screening phase: failure to record the daily symptom assessments in the diary cards for at least 7 days before baseline
✕. Gastroenteric: underlying gastrointestinal diseases including ulcerative colitis, Crohn's disease, pancreatitis, any active infectious, haemorrhagic or inflammatory disorder not related to IBS-D, gastrointestinal motility disorders such as ileus, gastroparesis or pseudoobstruction, gastroduodenal ulcer, gastrointestinal malignancy or potentially fatal diseases if not full in remission (5 years from diagnosis and without maintenance treatment), amyloidosis and cholelithiasis if cholecystectomy not performed
What they're measuring
1
Proportion of subjects with relief from abdominal pain and improved stool consistency.
✕. Intolerance: ascertained underlying lactose intolerance with response to diet or any other malabsorption syndrome with the exclusion of asymptomatic lactose malabsorption
✕. Coeliac disease: ascertained or presumptive underlying coeliac disease
✕. Bile: ascertained or presumptive bile acid malabsorption or bile acid induced diarrhoea