Study investigating the effect of baclofen in patients with postprandial regurgitation or belching

Phase 1

• Conditions: MedDRA version: 14.0Level: LLTClassification code 10004222Term: BelchingSystem Organ Class: 10017947 - Gastrointestinal disorders; Rumination syndrome and supragastric belching; MedDRA version: 14.0Level: LLTClassification code 10039292Term: Rumination disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-002745-35-BE
• Lead Sponsor: ZLeuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-19
• Study Completion: 2016-06-30
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Patients with clinical suspicion of rumination syndrome or supragastric belching

2. 18 to 75 years old.

3.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.

4.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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Systemic diseases, known to affect esophageal motility.
2.Surgery in thorax or in the upper part of the abdomen.
3.Treatment with baclofen prior to the start of the study.
4.Significant neurological, respiratory, hepatic, renal, haematological, cardiovascular, metabolic or gastroinestinal cerebrovascular disease as judged by the investigator
5.Pregnancy or breast feeding.
6.History of poor compliance. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent. (well-controlled depression is allowed).
7.History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The Primary objective of this study is to assess the efficacy (assessed by High resolution impedance-manometry recordings and questionnaires) of baclofen (lioresal®) 10mg three times daily vs. placebo in patients with clinical suspicion of rumination or supragastric belching.;Secondary Objective: The secondary objective is to assess the mechanism by which baclofen reduces postprandial flow events in patients with rumination of supragastric belching.;Primary end point(s): The primary efficacy endpoint will be the occurrence of gas and liquid flow events and symptoms identified during manometry-impedance recordings. ;Timepoint(s) of evaluation of this end point: Manometry-impedance recordings will be performed at 14 days after treatment initiation. After the cross over a second measurement will be performed after 14 days of treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary efficacy endpoint will be symptoms severity assessed by the PAGI-SYM and PAGI-QOL questionnaires.;Timepoint(s) of evaluation of this end point: Symptom severity will be evaluated using standerdized questionnaires at baseline, 14 days (end of treatment period 1) and 35 days (end of treatment period 2)