Efficacy and Safety of Mebeverine + Simethicone in Patients With Functional Bowel Disorders

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,
• condom or diaphragm (barrier method) with spermicide, or
• an intrauterine device

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;
• 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);
• Elevated fecal calprotectin level 1 month before or at screening which indicates the presence of inflammatory GIT disease;
• Unexplained GI bleeding within 3 months prior to screening;
• Confirmed diagnosis of bile acids malabsorption;
• History of any malignant disease except basal cell carcinoma of skin and vesical cervix carcinoma in situ which were cured ≥ 5 years ago;
• Confirmed diagnosis of celiac disease;
• Confirmed hereditary galactose or fructose intolerance , total lactase deficiency, sucrase-isomaltose insufficiency, glucose-galactose malabsorption syndrome;
• Diet changes (e.g, switching to fermented foods, a gluten-free diet) within the 1 months prior to screening;
• Planned elective surgery during the study;
• Pancreatic exocrine insufficiency or acute pancreatitis;
• Endometriosis in women;
• Positive results of tests for HIV, hepatitis B or C, at the moment of screening;
• Drugs or alcohol abuse at screening or in the past, which, in the Investigator's opinion, makes the patient not eligible for participation in the study;
• Participation in another clinical study or another study drug administration