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Clebopride Hydrogen Maleate

A clinical trial is currently underway to evaluate the effectiveness of Clebopride Hydrogen Maleate in treating Rumination Syndrome. This randomized, double-blind, placebo-controlled study aims to assess the drug’s impact on patients’ symptoms and overall quality of life. The trial focuses on adults with suspected Rumination Syndrome and explores various aspects of the condition using advanced diagnostic techniques.

Table of Contents

What is Clebopride?

Clebopride, also known by its full chemical name clebopride hydrogen maleate, is a medication that belongs to a class of drugs called prokinetics[1]. Prokinetics are medications that help improve the movement of the digestive system. In some countries, clebopride is marketed under the brand name Motilex and is available as 0.5 mg tablets[1].

Understanding Rumination Syndrome

Rumination syndrome is a condition where people repeatedly and unintentionally regurgitate undigested or partially digested food from the stomach back into the mouth[1]. This happens shortly after eating and is different from vomiting. People with rumination syndrome often rechew and reswallow the food. This condition can be distressing and affect a person’s quality of life.

How Clebopride May Help with Rumination Syndrome

Clebopride is being studied as a potential treatment for rumination syndrome. It works by:

  • Increasing the movement of the stomach and intestines, which may help food move through the digestive system more quickly
  • Potentially reducing the number of times food comes back up into the mouth
  • Possibly improving the function of the lower esophageal sphincter (LES), which is the muscle that prevents stomach contents from flowing back into the esophagus

Current Clinical Trial on Clebopride for Rumination Syndrome

A clinical trial is currently being conducted to evaluate the effectiveness of clebopride in treating rumination syndrome[1]. This trial is important because while clebopride is sometimes used in clinical practice for this condition, there isn’t enough scientific evidence yet to prove how well it works.

Key details of the trial include:

  • It’s a randomized, double-blind, placebo-controlled, crossover trial. This means that participants will receive both clebopride and a placebo at different times, and neither the participants nor the researchers will know which is being given when.
  • The dose being studied is 0.5 mg of clebopride taken three times a day.
  • The main goal is to see how well patients feel the treatment is working overall.
  • Researchers will also look at how clebopride affects various aspects of digestive function, such as the number of symptom events, the pressure of the lower esophageal sphincter, and the number of times the LES relaxes.

Who Can Participate in the Clinical Trial?

The trial has specific criteria for who can participate[1]. Some key points include:

  • Participants must be at least 18 years old
  • They should have a history consistent with probable rumination syndrome, as assessed by a gastroenterologist
  • They must have had a gastro-duodenoscopy (a type of endoscopy) within the past 12 months showing no abnormalities in the stomach or esophagus that could explain their symptoms
  • Participants must have tried a specific dose of omeprazole (a common acid-reducing medication) for at least 2 weeks before joining the study

There are also several conditions that would prevent someone from participating, such as:

  • Severe erosive esophagitis
  • Pregnancy or breastfeeding
  • Certain psychiatric illnesses
  • History of alcohol or drug abuse
  • Certain systemic diseases that affect esophageal motility
  • Parkinson’s syndrome or related conditions
  • Use of certain medications that might interfere with the study

What to Expect During the Trial

If you participate in the trial, you can expect[1]:

  • To take either clebopride or a placebo for a period of time, then switch to the other
  • To undergo tests such as high-resolution impedance manometry (HRiM), which measures pressures and movements in your esophagus
  • To keep a daily symptom diary
  • To complete questionnaires about your symptoms and quality of life

Potential Benefits and Considerations

Participating in this trial could potentially help improve your rumination syndrome symptoms. However, it’s important to remember that:

  • The effectiveness of clebopride for rumination syndrome is still being studied
  • You may experience side effects, which your doctor can discuss with you
  • You may receive a placebo for part of the study
  • The study involves several medical procedures and requires a time commitment

Always consult with your healthcare provider to determine if participating in this clinical trial is right for you. They can provide more detailed information about the potential risks and benefits based on your individual health situation.

Aspect Details
Study Design Randomized, double-blind, placebo-controlled, crossover trial
Condition Studied Rumination Syndrome
Drug Tested Clebopride Hydrogen Maleate
Dosage 0.5 mg three times daily (maximum 1.5 mg/day)
Primary Outcome Patient’s perceived overall treatment evaluation (OTE)
Key Secondary Outcomes Symptom severity, number of symptom events, esophageal function measurements, quality of life
Main Inclusion Criteria Adults (18+) with suspected Rumination Syndrome, normal gastro-duodenoscopy within 12 months
Key Exclusion Criteria Severe erosive esophagitis, pregnancy, certain medical conditions, use of specific medications

FAQ

  • What is Rumination Syndrome? Rumination Syndrome is a digestive condition where people repeatedly and unintentionally regurgitate undigested or partially digested food from the stomach back into the mouth. This usually occurs shortly after eating.
  • How is Clebopride being tested in this trial? Clebopride is being tested in a randomized, double-blind, placebo-controlled, crossover trial. Patients will receive either Clebopride or a placebo, and then switch to the other treatment. This allows researchers to compare the effects of the drug against a placebo in the same individuals.
  • What is the dosage of Clebopride used in the study? The study uses Clebopride at a dosage of 0.5 mg three times a day (t.i.d.), with a maximum daily dose of 1.5 mg.
  • What are the main outcomes being measured in this trial? The main outcome is the patients' perceived overall treatment evaluation, measured using a Likert score. Secondary outcomes include changes in symptom severity, number of symptom events, esophageal function measurements, and quality of life assessments.
  • Who can participate in this clinical trial? Participants must be at least 18 years old, have a history consistent with probable Rumination Syndrome, and have completed a gastro-duodenoscopy within the past 12 months showing no abnormalities. They must also have tried omeprazole for 2 weeks prior to the study. Certain medical conditions and medications may exclude participation.

Ongoing Clinical Trials on Clebopride Hydrogen Maleate

  • Study on Clebopride for Treating Rumination Syndrome in Patients Suspected of Having the Condition

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

Glossary

  • Rumination Syndrome: A digestive disorder where people repeatedly and unintentionally bring up (regurgitate) undigested or partially digested food from the stomach, rechew it, and then either reswallow it or spit it out.
  • Clebopride Hydrogen Maleate: The active ingredient being studied in this trial, which belongs to a class of drugs called prokinetics that can help with digestive issues.
  • Placebo: A substance with no active medical effects, used as a control in testing new drugs to help determine their effectiveness.
  • Double-blind: A study design where neither the participants nor the researchers directly involved know who is receiving the actual treatment and who is receiving a placebo.
  • Crossover trial: A type of clinical study where participants receive one treatment for a period, then switch to another treatment, allowing comparison of effects within the same individual.
  • High-resolution impedance manometry (HRiM): A diagnostic test that measures pressures and movement within the esophagus to assess its function.
  • Lower esophageal sphincter (LES): A ring of muscle that acts as a valve between the esophagus and stomach.
  • Transient LES relaxations (TLESRs): Brief periods when the lower esophageal sphincter relaxes, allowing stomach contents to flow back into the esophagus.
  • Likert score: A scale used to represent people's attitudes to a topic, usually ranging from one extreme to another (e.g., strongly disagree to strongly agree).
  • Gastro-duodenoscopy: A procedure that uses a camera to examine the upper part of the digestive system, including the esophagus, stomach, and first part of the small intestine.

References

  1. http://clinicaltrials.eu/trial/study-on-clebopride-for-treating-rumination-syndrome-in-patients-suspected-of-having-the-condition/