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Clebopride for the treatment of Rumination
EU CTIS ID: 2024-516573-71-00
What this study is testing
To assess the efficacy of clebopride 0.5 mg t.i.d. on the perceived overall treatment evaluation (by means of a Likert scoring system)
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Minimum 18 years old.
- History assessed by a gastroenterologist consistent with probable rumination syndrome.
- Have completed a gastro-duodenoscopy, within 12 months, showing no anatomical abnormality of the stomach or esophagus, which can explain the patients’ symptoms.
- Patients will have to have tried the equivalent of 20mg of daily omeprazole for 2 weeks prior to consideration of inclusion in the study.
- Sexually active women of child bearing potential participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception.
- Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.
You likely can't join if
- Endoscopic signs of severe erosive esophagitis (≥ grade B, Los Angeles classification) on endoscopy performed during PPI treatment in the 12 months prior to screening.
- Pregnancy or breast-feeding.
- History of poor compliance.
- History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
- History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
- Systemic diseases, known to affect esophageal motility.
See the full eligibility criteria
- Minimum 18 years old.
- History assessed by a gastroenterologist consistent with probable rumination syndrome.
- Have completed a gastro-duodenoscopy, within 12 months, showing no anatomical abnormality of the stomach or esophagus, which can explain the patients’ symptoms.
- Patients will have to have tried the equivalent of 20mg of daily omeprazole for 2 weeks prior to consideration of inclusion in the study.
- Sexually active women of child bearing potential participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception.
- Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.
- Endoscopic signs of severe erosive esophagitis (≥ grade B, Los Angeles classification) on endoscopy performed during PPI treatment in the 12 months prior to screening.
- Pregnancy or breast-feeding.
- History of poor compliance.
- History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
- History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
- Systemic diseases, known to affect esophageal motility.
- Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed).
- QTc>450 ms.
- Parkinson’s syndrome or related syndromes.
- History of adverse drug reactions (pseudo-Parkinsonism, tardive dyskinesia, restless legs) upon exposure to dopaminergic drugs.
- Concomitant use of medications such as anticholinergics, tricycle antidepressants, baclofen, dopamine antagonists or dopaminergic drugs and prokinetics.
- Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.
- Major psychiatric disorder – as determined by the clinicians.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.