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

NCT05175131 | Completed Phase 3 Results

• 1 other identifier: MESI3001
• Study Type: interventional
• Target: 465
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Functional Bowel Disorder

Keywords

Mebeverine+Simethicone; Duspatalin; abdominal pain; bloating/flatulence; functional bowel disorder; fixed dose combination; NRS11

Outcome Measures

Primary Outcomes (1)

• Change From Baseline of Sum of NRS-11 Abdominal Pain and Bloating/Flatulence Intensity Scores After 4 Weeks of Treatment.

  The baseline abdominal pain and bloating/flatulence intensity was determined as the average of the Numeric rating scale (NRS-11) daily assessment during 7 days before randomization. The Week 4 assessment was the average from last 7 days of the corresponding week. The scale is a horizontal 10 cm line with the numbers from 0 to 10 located on it, where 0 is "no pain/bloating", 10 is "most severe pain/bloating you can imagine".

  4 weeks

Secondary Outcomes (4)

• Change From Baseline of NRS-11 Pain Intensity After 4 Weeks of Treatment

  4 weeks

• Change From Baseline of NRS-11 Bloating/Flatulence Intensity After 4 Weeks of Treatment

  4 weeks

• Change in Number of Days Per Week During Study Treatment Period When Drotaverine Was Taken.

  4 weeks

• Change in Quality of Life Evaluation Using IBSQOL Questionnaire Versus Baseline.

  4 weeks

Study Arms (3)

Mebeverine+Simethicone combination

EXPERIMENTAL

three times a day per os

Drug: Mebeverine+Simethicone

mebeverine

ACTIVE COMPARATOR

three times a day per os

Drug: Mebeverine

simethicone

ACTIVE COMPARATOR

80 mg (2 capsules 40 mg) three times a day per os

Drug: Simethicone

Interventions

Mebeverine+Simethicone DRUG

fixed-dose combination, film-coated tablets, 135 mg + 80 mg

Mebeverine+Simethicone combination

Mebeverine DRUG

Duspatalin®, coated tablets 135 mg

mebeverine

Simethicone DRUG

Espumisan® capsules 40 mg

simethicone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Null Research Facilities

Moscow, Russia

Location

MeSH Terms

Conditions

Abdominal Pain; Flatulence

Interventions

mebeverine; Simethicone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Suntje Sander-Struckmeier, PhD
• Organization: Abbott

suntje.sander@abbott.com

+49 (0) 511 6750 3254

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 3, 2022
• Study Start: November 27, 2020
• Primary Completion: May 18, 2021
• Study Completion: May 18, 2021
• Last Updated: September 16, 2025
• Results First Posted: January 3, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)