Study to investigate the effectiveness of mebeverine versus placebo in children with functional bowel disorders

Phase 1

• Conditions: Functional Gastrointestinal Disorders (Irritable Bowel Syndrome or Functional Abdominal Pain - not otherwise specified); MedDRA version: 20.1Level: LLTClassification code 10064907Term: Functional abdominal painSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 20.1Level: PTClassification code 10023003Term: Irritable bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-003293-32-NL
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-01
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 284

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
All children aged between 12 and 18 years diagnosed with irritable bowel syndrome or functional abdominal pain – not otherwise specified according to the Rome IV criteria will be invited to participate. The Rome IV criteria form the internationally accepted standard for defining functional gastrointestinal disorders like irritable bowel syndrome and functional abdominal pain – not otherwise specified.1 Before inclusion, all patients undergo routine laboratory testing to exclude underlying organic disorders: complete blood cell count, C-reactive protein, celiac screening (anti-transglutaminase antibodies and IgA), fecal screening on Giardia lamblia if patient presents with diarrhea, and on calprotectin in case an Inflammatory Bowel Disease is suspected. The need for further diagnostic testing is left to the discretion of the treating physician.
Finally, according to a recently published guideline by the Rome Foundation for the design of pharmacological clinical trials in children, patients are required to have an average daily pain rate of =2 on the Wong Baker Faces Pain Scale. This is a validated pain scale to measure pain intensity.
In addition, Informed Consent by both parents and by children aged = 12 years is a necessity before children can be included in the study.

Rome IV criteria for irritable bowel syndrome (IBS) in children and adolescents:
Diagnostic criteria* must include all of the following:
-Abdominal pain at least 4 days per month associated with one or more of the following:
a.Related to defecation
b.A change in frequency of stool
c.A change in form (appearance) of stool
-In children with constipation, the pain does not resolve with resolution of the constipation (children in whom the pain resolves have functional constipation, not irritable bowel syndrome)
-After appropriate evaluation, the symptoms cannot be fully explained by another medical condition
* Criteria fulfilled for at least 2 months before diagnosis

Rome IV criteria for functional abdominal pain – not otherwise specified (FAP-NOS) in children and adolescents:
Diagnostic criteria* must be fulfilled 4 times per month and include all of the following:
1.Episodic or continuous abdominal pain that does not occur solely during physiologic events (e.g., eating, menses)
2.Insufficient criteria for irritable bowel syndrome, functional dyspepsia, or abdominal migraine
3.After appropriate evaluation, the abdominal pain cannot be fully explained by another medical condition.
* Criteria fulfilled at least 2 months before diagnosis.

Are the trial subjects under 18? yes
Number of subjects for this age range: 284
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Current treatment by another health care professional for abdominal symptoms
•Previous use of mebeverine
•Known hypersensitivity to the active substance or to any of the excipients (magnesium stearate, polyacrylate dispersion, talc, hypromellose, methacrylic acid – ethyl acrylate copolymer (1:1) dispersion, glycerol triacetate, gelatine, titanium dioxide (E171), shellac (E904), propylene glycol, ammonia solution (concentrated), potassium hydroxide, iron oxide black (E172)).
•Known diagnosis of cystic fibrosis
•Known diagnosis of porphyria
•Known concomitant organic gastrointestinal disease
•Current use of drugs which influence gastrointestinal motility, such as erythromycin, azithromycin, domperidone, and Iberogast.
•Insufficient knowledge of the Dutch language
•Known pregnancy or current lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified