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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.

Russia1 site

Null Research Facilities
Moscow

Other trials in Russia

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

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 groups in NCT05175131
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.

27 Nov 202018 May 2021

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Functional Bowel Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05175131
Acronym / sponsor ID: MESI3001
Conditions: Functional Bowel Disorder
Keywords: Mebeverine+Simethicone, Duspatalin, abdominal pain, bloating/flatulence, functional bowel disorder, fixed dose combination, NRS11
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 465 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: 27 Nov 2020 (actual)
Primary completion: 18 May 2021 (actual)
Study completion: 18 May 2021 (actual)
First posted: 3 Jan 2022 (actual)
Results: Posted 3 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Mebeverine+Simethicone combination	Experimental	Drug: Mebeverine+Simethiconethree times a day per os
mebeverine	Active comparator	Drug: Mebeverinethree times a day per os
simethicone	Active comparator	Drug: Simethicone80 mg (2 capsules 40 mg) three times a day per os

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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);

Key exclusion criteria (23 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mebeverine+Simethiconefixed-dose combination, film-coated tablets, 135 mg + 80 mg	Drug	Mebeverine+Simethicone combination
MebeverineDuspatalin®, coated tablets 135 mg	Drug	mebeverine
SimethiconeEspumisan® capsules 40 mg	Drug	simethicone

Primary outcome

Change From Baseline of Sum of NRS-11 Abdominal Pain and Bloating/Flatulence Intensity Scores After 4 Weeks of Treatment.
Time frame: 4 weeks
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 secondary outcomes

Change From Baseline of NRS-11 Pain Intensity After 4 Weeks of Treatment
Time frame: 4 weeks
Change From Baseline of NRS-11 Bloating/Flatulence Intensity After 4 Weeks of Treatment
Time frame: 4 weeks
Change in Number of Days Per Week During Study Treatment Period When Drotaverine Was Taken.
Time frame: 4 weeks
Change in Quality of Life Evaluation Using IBSQOL Questionnaire Versus Baseline.
Time frame: 4 weeks

Results and safety

Results posted to the registry on 3 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mebeverine+Simethicone Combination	155	153
Mebeverine	155	154
Simethicone	155	152

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

Time frame: 4 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Mebeverine+Simethicone Combination n = 154	Mebeverine n = 155	Simethicone n = 154
Value	-7.23 (3.42)	-6.48 (3.48)	-5.86 (3.72)

Mebeverine+Simethicone Combination vs Mebeverine: Mean Difference (Final Values): 1.1 (95% CI 0.3 to 1.8), p = 0.0042, ANCOVA
Mebeverine+Simethicone Combination vs Simethicone: Mean Difference (Final Values): 1.6 (95% CI 0.9 to 2.4), p <0.0001, ANCOVA

Population analysed: 465 subjects were allocated to treatment. 2 subjects had only a baseline assessment of the efficacy parameters and were excluded from the full analysis sample. Therefore, 463 subjects were included in the Full Analysis Sample (FAS)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Period for AEs collection was from the first study drug dose to the end of 30 days follow-up post-therapy period. Duration of treatment was 28 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mebeverine+Simethicone Combination	0 of 155 (0%)	39 of 155 (25.2%)	0 of 155
Mebeverine	1 of 155 (0.6%)	36 of 155 (23.2%)	0 of 155
Simethicone	0 of 155 (0%)	31 of 155 (20%)	0 of 155

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mebeverine+Simethicone, Mebeverine and Simethicone in people with Functional Bowel Disorder, run by Abbott at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline of Sum of NRS-11 Abdominal Pain and Bloating/Flatulence Intensity Scores After 4 Weeks of Treatment. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05175131.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.