Baclofen for Rumination

Rumination Clinical Trial

Official title:

A Double-blind, Placebo-controlled, Cross-over Study Using Baclofen in the Treatment of Rumination Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03113396
• Other study ID #: S53446
• Status: Completed
• Phase: Phase 4
• First received: March 21, 2017
• Last updated: April 8, 2017
• Start date: February 1, 2012
• Est. completion date: December 31, 2016

Study information

• Verified date: April 2017
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with a clinical suspicion of rumination syndrome and/or supra-gastric belching are randomized into baclofen or placebo for 2 weeks (10mg, tid). thereafter, they undergo a high resolution impedance manometry measurement, were they receive a solid meal, and recordings continue for another hour. Thereafter, they will receive the alternative treatment, after which they will undergo a second high resolution impedance manometry measurement. Patients are asked to fill out questionnaires during the entire study period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Clinical suspicion of rumination syndrome and/or supra-gastric belching.

• 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.

• 18 to 75 years old.

• 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:

• Systemic diseases, known to affect esophageal motility.

• Surgery in thorax or in the upper part of the abdomen.

• Treatment with baclofen prior to the start of the study.

• Significant neurological, respiratory, hepatic, renal, haematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.

• 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. (well-controlled depression is allowed).

• History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.

Related Conditions & MeSH terms

• Feeding and Eating Disorders of Childhood
• Rumination
• Supra-gastric Belching

Intervention

Drug:
• Baclofen
baclofen oral, 10mg, tid for 2 weeks (or placebo, identically looking capsules) after 2 weeks, patients undergo a High Resolution Impedance Manometry measurement with a meal period. Patients will fill out questionnaires concerning overall wellbeing.
• Placebo oral capsule
placebo oral, tid for 2 weeks after 2 weeks, patients undergo a High Resolution Impedance Manometry measurement with a meal period. Patients will fill out questionnaires concerning overall wellbeing.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall wellbeing of the patients, assessed by an overall treatment evaluation questionnaire.	patients fill out questionnaires concerning overall wellbeing, during the 2 weeks of treatment. Results of these questionnaires will be compared between both conditions (baclofen and placebo).	2 weeks treatment
Secondary	objective measurement of rumination / supra-gastric belching, using high resolution impedance manometry monitoring	High Resolution impedance Manometry monitoring will be performed, with a meal. We will look at the number of times patients push an event marker, the number of time patients ruminate or have supra-gastric belching or have reflux episodes, or have transient lower esophageal sphincter relaxations, both before and after the meal. And we will compare these outcomes between placebo and baclofen.	2 weeks treatment