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New combo pill targets tummy troubles: pain and gas relief in one

NCT ID NCT05175131

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a fixed-dose combination of Mebeverine (a muscle relaxant) and Simethicone (a gas reducer) against each drug alone in 465 adults with functional bowel disorders causing abdominal pain and bloating. The goal was to see if the combo pill better reduces pain and bloating after 4 weeks. Participants rated their symptoms daily on a 0-10 scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mebeverine + Simethicone fixed-dose combination
What this could lead to
If successful, this combination pill could offer a more convenient and effective way to relieve both abdominal pain and bloating in people with functional bowel disorders.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The combination may not prove significantly better than taking either drug alone, and individual responses vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

465 people

The number who actually took part.

Started

Nov 2020

Finished

May 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed Informed Consent Form; 2. Males and females aged 18 to 75 years old (inclusive); 3. Abdominal pain and bloating/flatulence due to functional bowel disorder (including IBS, chronic functional constipation, chronic functional diarrhea or functional abdominal bloating); 4. Episodes of abdominal pain for at least 3 months, with a frequency of at least 3 times a month; 5. 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); 6. 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); 7. Patients' consent to use adequate contraception methods throughout the study. Adequate contraception methods include: 1. oral contraceptives or contraceptive patches, 2. condom or diaphragm (barrier method) with spermicide, or 3. an intrauterine device Exclusion Criteria: 1. Hypersensitivity to mebeverine, simethicone, drotaverine, excipients of the studied products, or contraindications; 2. Intake of tricyclic antidepressants, eluxadoline, linaclotide, selective serotonin re-uptake inhibitors, rifaximin, lubriprostone within the last week before screening; 3. New prescription or any change in probiotic drug therapy (including change in the drug or dosage regimen) during the last month before screening; 4. 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); 5. 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); 6. 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; 7. 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; 8. Any inflammatory bowel disease (Crohn's disease, ulcerative colitis, any infection including bacterial, viral, protozoa, helminthosis); 9. Elevated fecal calprotectin level 1 month before or at screening which indicates the presence of inflammatory GIT disease; 10. Unexplained GI bleeding within 3 months prior to screening; 11. Confirmed diagnosis of bile acids malabsorption; 12. History of any malignant disease except basal cell carcinoma of skin and vesical cervix carcinoma in situ which were cured ≥ 5 years ago; 13. Confirmed diagnosis of celiac disease; 14. Confirmed hereditary galactose or fructose intolerance , total lactase deficiency, sucrase-isomaltose insufficiency, glucose-galactose malabsorption syndrome; 15. Diet changes (e.g, switching to fermented foods, a gluten-free diet) within the 1 months prior to screening; 16. Planned elective surgery during the study; 17. Pancreatic exocrine insufficiency or acute pancreatitis; 18. Endometriosis in women; 19. Positive results of tests for HIV, hepatitis B or C, at the moment of screening; 20. 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; 21. Participation in another clinical study or another study drug administration within 30 days prior to screening; 22. 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; 23. 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.

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Conditions

The condition(s) this trial relates to.

Abdominal Pain Flatulence functional colonic disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Null Research Facilities

    Moscow, Russia

More trials for these conditions

Other studies related to the condition(s) this trial covers.