Clebopride hydrogen maleate for Rumination Syndrome

Inclusion criteria

• {"criterion_text":"- Minimum 18 years old.\n- History assessed by a gastroenterologist consistent with probable rumination syndrome.\n- Have completed a gastro-duodenoscopy, within 12 months, showing no anatomical abnormality of the stomach or esophagus, which can explain the patients’ symptoms.\n- Patients will have to have tried the equivalent of 20mg of daily omeprazole for 2 weeks prior to consideration of inclusion in the study.\n- 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.\n- 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."}

Exclusion criteria

• {"criterion_text":"- Endoscopic signs of severe erosive esophagitis (≥ grade B, Los Angeles classification) on endoscopy performed during PPI treatment in the 12 months prior to screening.\n- Systemic diseases, known to affect esophageal motility.\n- Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed).\n- QTc>450 ms.\n- Parkinson’s syndrome or related syndromes.\n- History of adverse drug reactions (pseudo-Parkinsonism, tardive dyskinesia, restless legs) upon exposure to dopaminergic drugs.\n- Concomitant use of medications such as anticholinergics, tricycle antidepressants, baclofen, dopamine antagonists or dopaminergic drugs and prokinetics.\n- Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.\n- Major psychiatric disorder – as determined by the clinicians.\n- Pregnancy or breast-feeding.\n- History of poor compliance.\n- History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.\n- History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements."}

Primary endpoints

• {"endpoint_text":"- The patients perceived overall treatment evaluation (OTE), which will be obtained using a Likert score between -4 and +4.","definition_or_measurement_approach":"Obtained using a Likert score between -4 and +4 (patient perceived overall treatment evaluation)."}

Secondary endpoints

• {"endpoint_text":"- The overall symptom severity (OSS) compared between both treatment periods . The OSS will be filled out at the end of each treatment period, and numbers will be compared between the two treatment periods.","definition_or_measurement_approach":"Overall Symptom Severity (OSS) questionnaire filled out at the end of each treatment period; scores compared between periods."}
• {"endpoint_text":"- The difference between receiving clebopride and placebo in the number of symptom events identified by the patient during HRiM. Patients will have to push a symptom marker during the HRiM measurement. Different markers will be used for different symptoms","definition_or_measurement_approach":"Number of patient-marked symptom events during High Resolution impedance Manometry (HRiM); patients press a symptom marker during HRiM; different markers for different symptoms."}
• {"endpoint_text":"- Number of flow events during HRiM.","definition_or_measurement_approach":"Count of flow events measured during HRiM."}
• {"endpoint_text":"- EGJ pressure during HRiM. The averages after a meal period will be compared between placebo and clebopride condition","definition_or_measurement_approach":"Esophagogastric junction (EGJ) pressure measured during HRiM; average post-meal EGJ pressures compared between conditions."}
• {"endpoint_text":"- Number of TLESRs. The number of TLESRs will be compared between placebo and clebopride condition","definition_or_measurement_approach":"Count of transient lower esophageal sphincter relaxations (TLESRs) during HRiM; compared between conditions."}
• {"endpoint_text":"- Number of events with increased Intra-gastric pressure","definition_or_measurement_approach":"Count of events with increased intragastric pressure measured during monitoring."}
• {"endpoint_text":"- Daily Symptom Diary Leuven Postprandial Distress Scale (LPDS) diary with additional question concerning retrograde bolus flow","definition_or_measurement_approach":"Daily symptom diary using Leuven Postprandial Distress Scale (LPDS) with added question on retrograde bolus flow; diary entries analysed."}
• {"endpoint_text":"- Symptom severity at week 2 (PAGI-SYM)","definition_or_measurement_approach":"Symptom severity measured at week 2 using PAGI-SYM questionnaire."}
• {"endpoint_text":"- Quality of life at week 2 (PAGI-QOL)","definition_or_measurement_approach":"Quality of life measured at week 2 using PAGI-QOL questionnaire."}

Belgium

Earliest CTIS Part Ii Submission Date

28-10-2024

Latest Decision Or Authorization Date

29-10-2024

Processing Time Days

1

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

UZ Leuven

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium