- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03113396
Baclofen for Rumination
April 8, 2017 updated by: Prof Dr Jan Tack, Universitaire Ziekenhuizen KU Leuven
A Double-blind, Placebo-controlled, Cross-over Study Using Baclofen in the Treatment of Rumination Syndrome
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: baclofen
Patients will receive baclofen (10mg t.i.d) for 2 weeks, thereafter they will be crossed over to the alternative treatment, which is placebo (identically looking capsules).
After 2 weeks of treatment, patients will undergo a High Resolution Impedance Manometry (HRiM) measurement, with meal.
We will record for in total 2 hours.
Patients are asked to fill out questionnaires concerning their overall wellbeing.
|
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.
Other Names:
|
Placebo Comparator: placebo
Patients will receive placebo for 2 weeks, thereafter they will be crossed over to the alternative treatment, which is baclofen (10mg t.i.d) (identically looking capsules).
After 2 weeks of treatment, patients will undergo a High Resolution Impedance Manometry (HRiM) measurement, with meal.
We will record for in total 2 hours.
Patients are asked to fill out questionnaires concerning their overall wellbeing.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall wellbeing of the patients, assessed by an overall treatment evaluation questionnaire.
Time Frame: 2 weeks treatment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
objective measurement of rumination / supra-gastric belching, using high resolution impedance manometry monitoring
Time Frame: 2 weeks treatment
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2012
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
December 31, 2016
Study Registration Dates
First Submitted
March 21, 2017
First Submitted That Met QC Criteria
April 8, 2017
First Posted (Actual)
April 13, 2017
Study Record Updates
Last Update Posted (Actual)
April 13, 2017
Last Update Submitted That Met QC Criteria
April 8, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Digestive System Diseases
- Feeding and Eating Disorders
- Gastrointestinal Diseases
- Rumination Syndrome
- Feeding and Eating Disorders of Childhood
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- GABA Agents
- Neuromuscular Agents
- Muscle Relaxants, Central
- GABA Agonists
- GABA-B Receptor Agonists
- Baclofen
Other Study ID Numbers
- S53446
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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