Mebeverine Hydrochloride

Clinical trials are studying Mebeverine Hydrochloride in people with irritable bowel syndrome. The trials aim to compare its clinical effect with another treatment and to measure symptom relief, pain, and quality of life. This article explains the study goals, phase, target population, and main outcomes.

Table of contents

Trial overview

The provided data includes one randomized controlled clinical trial studying Mebeverine Hydrochloride in people with irritable bowel syndrome.[1] The trial is titled as a multicenter study comparing ebastine and mebeverine as treatment for this condition.[1]

The study is authorised and plans to enroll 200 participants.[1] The trial is interventional, which means the researchers give treatments and then measure the effects.[1]

Study design and phase

This study is in Phase 3, which is a later stage of clinical testing.[1] Phase 3 studies usually compare treatments in larger groups to see how well they work in real patients.[1]

The brief summary says the trial is a randomized superiority trial.[1] In simple words, this means people are assigned by chance to treatment groups, and the study is designed to see whether one treatment works better than the other.[1]

The treatments listed are ebastine and Duspatalin Retard 200 mg capsules, with dummy treatments also included in the study design.[1] The source data also names the study as multicenter, which means it is carried out at more than one study site.[1]

Who is being studied

The target population is people with irritable bowel syndrome.[1] No more detailed inclusion or exclusion rules are given in the provided trial data, so the exact participation criteria are not available here.[1]

This means the article can only confirm the overall condition being studied, not the full list of who may join the trial.[1]

What is being measured

The main outcomes are abdominal pain intensity and global relief of symptoms.[1] Abdominal pain intensity shows how strong the pain is, while global relief of symptoms looks at overall improvement from the patient’s point of view.[1]

The study also aims to evaluate the impact of treatment on quality of life and quality-adjusted life years.[1] Quality of life means how much the condition affects daily living and well-being, while quality-adjusted life years is a measure that combines how long people live with how well they feel during that time.[1]

Why this trial matters

This trial is important because it focuses on patient-relevant results such as pain, symptom relief, and daily life impact.[1] It is not just asking whether treatment works in theory, but whether people feel better in ways that matter in everyday life.[1]

Since the study compares Mebeverine Hydrochloride with another treatment, it may help show how the treatment performs against an active comparator in irritable bowel syndrome.[1] The available data does not report final results, so the trial should be seen as a study design summary rather than proof of benefit.[1]

Trial ID Phase Condition studied Status Enrollment
2022-501780-41-00 Phase 3 Irritable Bowel Syndrome Authorised 200

Igangværende kliniske forsøg for Mebeverine Hydrochloride

  • Sammenligning af ebastine og mebeverine til behandling af irritabel tyktarm (IBS) hos voksne

    Rekrutterer

    1 1 1
    Undersøgte lægemidler:
    Belgien

Ordliste

  • Irritable bowel syndrome: A long-term condition that affects the bowel and can cause abdominal pain, bloating, and changes in bowel habits.
  • Randomized trial: A study where participants are assigned by chance to different treatment groups. This helps make the comparison fair.
  • Controlled trial: A study that compares one treatment with another treatment or a dummy treatment, also called a placebo.
  • Phase 3: A later stage of clinical research that studies how well a treatment works and gathers more safety and effectiveness data.
  • Interventional study: A study where researchers give a treatment and then measure the effects.
  • Abdominal pain intensity: How strong the stomach or belly pain is. This is often measured to see whether treatment helps.
  • Global relief of symptoms: A broad measure of whether a person feels overall improvement in their symptoms.
  • Quality of life: How a health condition affects daily life, comfort, and well-being.
  • Quality-adjusted life years: A way to measure both how long people live and how well they feel during that time.
  • Randomized superiority trial: A study designed to see whether one treatment works better than another.

Referencer

  1. https://clinicaltrials.gov/study/2022-501780-41-00