Functional Bowel DisorderPhase 3NCT05175131
Efficacy and Safety of Mebeverine + Simethicone in Patients With Functional Bowel Disorders
A Phase 3 study testing Mebeverine+Simethicone, Mebeverine and Simethicone in people with Functional Bowel Disorder, run by Abbott at 1 site in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Functional Bowel Disorder
- What is being tested?
- Mebeverine+Simethicone, Mebeverine and Simethicone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 465 participants
- Where
- 1 siteRussia
- Study dates
- 27 Nov 2020to 18 May 2021
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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
Who cannot join
- 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;
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- 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 within 30 days prior to screening;
- Pregnant or lactating women, or women planning to get pregnant during the clinical study; women of child-bearing potential (including those without history of surgical sterilization and women with <2 years post-menopause) not using adequate contraception methods;
- Inability to read or right; unwillingness to understand and comply with Protocol procedures; non-compliance with medication dosing regimen or procedures which, in the Investigator's opinion, may affect study results or the patient's safety and prevent the patient's participation in the study; any other concomitant diseases or severe mental disorders, which make the patient ineligible for study participation, limit the legal basis for Informed Consent procedure, or may affect the patient's ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Randomized, Parallel-group, Open-label, Comparative Clinical Study to Evaluate Efficacy and Safety of Mebeverine+Simethicone Fixed-dose Combination Versus Duspatalin® (Mebeverine) and Versus Espumisan® (Simethicone) in Patients With Functional Bowel Disorders With Abdominal Pain and Excess Gas Formation
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
- Being tested
- Mebeverine+Simethicone, Mebeverine, Simethicone
- Keywords
- Mebeverine+Simethicone, Duspatalin, abdominal pain, bloating/flatulence, functional bowel disorder, fixed dose combination, NRS11
- Medical subject headings
- Abdominal Pain, Flatulence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mebeverine+SimethiconeDrug
fixed-dose combination, film-coated tablets, 135 mg + 80 mg
MebeverineDrug
Duspatalin®, coated tablets 135 mg
SimethiconeDrug
Espumisan® capsules 40 mg
| Study group | Role | What they receive |
|---|---|---|
| Mebeverine+Simethicone combination | Experimental | three times a day per os Receives: Drug: Mebeverine+Simethicone |
| mebeverine | Active comparator | three times a day per os Receives: Drug: Mebeverine |
| simethicone | Active comparator | 80 mg (2 capsules 40 mg) three times a day per os Receives: Drug: Simethicone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 4 weeks
Secondary outcomes (4)
Change From Baseline of NRS-11 Pain Intensity After 4 Weeks of Treatment
The baseline pain 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".
Measured: 4 weeks
Change From Baseline of NRS-11 Bloating/Flatulence Intensity After 4 Weeks of Treatment
The baseline 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".
Measured: 4 weeks
Change in Number of Days Per Week During Study Treatment Period When Drotaverine Was Taken.
The data from last week of screening and run-in period was used for baseline assessment of number of days of drotaverin intake. Week 1, Week 2, Week3 and Week 4 assessments were the data from the last 7 days of the corresponding week.
Measured: 4 weeks
Change in Quality of Life Evaluation Using IBSQOL Questionnaire Versus Baseline.
Patients were asked to evaluate the quality of life using the Irritable bowel syndrome quality of life (IBSQOL) questionnaire at baseline at Visit 2 (Week 0) and at the end of the study treatment at Visit 3 (Week 4).
The individual responses to the 34 items were summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start27 Nov 2020
- Primary completion18 May 2021
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Functional Bowel DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175131
- Sponsor's protocol ID
- MESI3001
- Status last verified
- Sep 2025
- First submitted
- 14 Dec 2021
- Last updated
- 16 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No