rumination syndrome
Conditions
Interventions
Trade Name: Cleboril
Pharmaceutical Form: Tablet
INN or Proposed INN: CLEBOPRIDE
CAS Number: 55905-53-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmac
Sponsors
KU Leuven - TARGID
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Minimum 18 years old. 2. History assessed by a gastroenterologist consistent with probable rumination syndrome. 3. Have completed a gastro-duodenoscopy, within 12 months, showing no anatomical abnormality of the stomach or esophagus, which can explain the patients’ symptoms. 4. Patients will have to have tried the equivalent of 20mg of daily omeprazole for 2 weeks prior to consideration of inclusion in the study. 5. 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. 6. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Endoscopic signs of severe erosive esophagitis (= grade B, Los Angeles classification) on endoscopy performed during PPI treatment in the 12 months prior to screening. 2. Systemic diseases, known to affect esophageal motility. 3. Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed). 4. QT c>450 ms. 5. Parkinson’s syndrome or related syndromes. 6. History of adverse drug reactions (pseudo-Parkinsonism, tardive dyskinesia, restless legs) upon exposure to dopaminergic drugs. 7. Concomitant use of medications such as anticholinergics, tricycle antidepressants, baclofen, dopamine antagonists or dopaminergic drugs and prokinetics. 8. Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator. 9. Major psychiatric disorder – as determined by the clinicians. 10. Pregnancy or breast-feeding. 11. History of poor compliance. 12. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent. 13. History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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);Secondary Objective: To assess the effect of clebopride on the number of symptom events, indicated by the patient, during high-resolution impedance manometry, the number of flow event identified on High Resolution impedance Manometry (HRiM), lower esophageal sphincter (LES) pressure, the number of transient LES relaxations (TLESRs) and on intra-gastric pressure;Primary end point(s): •Difference in overall treatment evaluation (OTE) between clebopride and placebo in the treatment of rumination syndrome ;Timepoint(s) of evaluation of this end point: after 2 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Difference in overall symptom severity (OSS) between treatment with clebopride and placebo • Difference in number of symptom events, as indicated by the patients during HRiM, between treatment with clebopride and placebo • Difference in number of flow events during HRiM between treatment with clebopride and placebo o Gastro-oesophageal reflux o Rumination: ? Primary Rumination ? Secondary Rumination ? Supra-gastric belch associated rumination o Supra-gastric belching o Gastric belching • Difference in esophago-gastric junction (EGJ) pressure (mmHg) during HRiM between treatment with clebopride and placebo • Difference in number of TLESRs during HRiM between both treatment periods • Difference in intragastric pressure (mmHg) during HRiM between both treatment periods • Difference in number of events with increased intra-gastric pressure during HRiM between both treatment periods • Difference in number of symptoms as assessed by a daily symptom diary (Leuven Postprandial Distress Scale) between both treatment periods • Difference in symptom severity assessed at the end of each treatment period between both treatment periods • Difference in quality of Life assessed at the end of each treatment period between both treatment periods ;Timepoint(s) of evaluation of this end point: after 2 weeks of treatment | — |
Countries
Belgium
Contacts
Public ContactAns Pauwels
KU Leuven - TARGID
Outcome results
None listed