Efficacy and Safety of Mebeverine + Simethicone in Patients With Functional Bowel Disorders (NCT05175131) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Mebeverine + Simethicone in Patients With Functional Bowel Disorders
Russia465 participantsStarted 2020-11-27
Plain-language summary
The parallel three-group study of efficacy and safety was planned to investigate the reduction in abdominal pain and bloating during treatment with the fixed-dose combination of Mebeverine + Simethicone versus Duspatalin® and Espumisan® as a monotherapy (Protocol No. MESI3001).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Signed Informed Consent Form;
✓. Males and females aged 18 to 75 years old (inclusive);
✓. Abdominal pain and bloating/flatulence due to functional bowel disorder (including IBS, chronic functional constipation, chronic functional diarrhea or functional abdominal bloating);
✓. Episodes of abdominal pain for at least 3 months, with a frequency of at least 3 times a month;
✓. Abdominal pain intensity of 4 to 9 points (inclusive) when assessed on the NRS-11 scale (i.e. weekly average, with daily recording of the worst pain for the last 24 hours during last week of Screening and Run-in period);
✓. Bloating/flatulence intensity of of 4 to 9 points (inclusive) when assessed on the NRS-11 scale (i.e. weekly average, with daily recording of the worst bloating episode for the last 24 hours during last week of Screening and Run-in period);
✓. Patients' consent to use adequate contraception methods throughout the study. Adequate contraception methods include:
✓. oral contraceptives or contraceptive patches,
Exclusion criteria
✕. Hypersensitivity to mebeverine, simethicone, drotaverine, excipients of the studied products, or contraindications;
✕. Intake of tricyclic antidepressants, eluxadoline, linaclotide, selective serotonin re-uptake inhibitors, rifaximin, lubriprostone within the last week before screening;
What they're measuring
1
Change From Baseline of Sum of NRS-11 Abdominal Pain and Bloating/Flatulence Intensity Scores After 4 Weeks of Treatment.
. New prescription or any change in probiotic drug therapy (including change in the drug or dosage regimen) during the last month before screening;
✕. History of intestinal obstruction, stricture, toxic megacolon, GI (gastro-intestinal) perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (e.g. aorto-iliac disease);
✕. History of major gastric, hepatic, pancreatic or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy allowed as long as occurred \> 3 months prior to trial screening; uncomplicated laparoscopic or open cholecystectomy is allowed if no history of post-operative biliary tract pain and surgery occurred \> 3 months prior to screening);
✕. Significant and progressive enlargement of the liver, spleen, lymph nodes; ascites; palpable tumor formation in the abdominal cavity / pelvis according to physical examination, hepatic cirrhosis;
✕. Significant concomitant acute or chronic disease (cardiovascular, gastrointestinal, endocrine, immunological, metabolic, bronchopulmonary, urinary system) or any condition that, according to Investigator, is a contraindication for the patient to participate in the study if interference with the study performance;
✕. Any inflammatory bowel disease (Crohn's disease, ulcerative colitis, any infection including bacterial, viral, protozoa, helminthosis);