Clebopride for the treatment of Rumination

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Trial duration

3 Oct 2019 → ongoing

Decision date (initial)

2024-10-29

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-516573-71-00

EudraCT number

2019-002185-13

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

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 objectives 1

1. 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

Conditions and MedDRA coding

Rumination Syndrome

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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.

Exclusion criteria 13

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. QTc>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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The patients perceived overall treatment evaluation (OTE), which will be obtained using a Likert score between -4 and +4.

Secondary endpoints 9

1. 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.
2. 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
3. Number of flow events during HRiM.
4. EGJ pressure during HRiM. The averages after a meal period will be compared between placebo and clebopride condition
5. Number of TLESRs. The number of TLESRs will be compared between placebo and clebopride condition
6. Number of events with increased Intra-gastric pressure
7. Daily Symptom Diary Leuven Postprandial Distress Scale (LPDS) diary with additional question concerning retrograde bolus flow
8. Symptom severity at week 2 (PAGI-SYM)
9. Quality of life at week 2 (PAGI-QOL)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Jan Tack

Public contact point

Organisation

UZ Leuven

Contact name

Jan Tack

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications