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Baclofen for Rumination

Primary Purpose

Rumination, Supra-gastric Belching

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Baclofen
Placebo oral capsule
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rumination

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    baclofen

    placebo

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    March 21, 2017
    Last Updated
    April 8, 2017
    Sponsor
    Universitaire Ziekenhuizen KU Leuven
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03113396
    Brief Title
    Baclofen for Rumination
    Official Title
    A Double-blind, Placebo-controlled, Cross-over Study Using Baclofen in the Treatment of Rumination Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2012 (Actual)
    Primary Completion Date
    December 31, 2016 (Actual)
    Study Completion Date
    December 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitaire Ziekenhuizen KU Leuven

    4. Oversight

    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

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rumination, Supra-gastric Belching

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    baclofen
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Baclofen
    Other Intervention Name(s)
    Lioresal
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo oral capsule
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Overall wellbeing of the patients, assessed by an overall treatment evaluation questionnaire.
    Description
    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).
    Time Frame
    2 weeks treatment
    Secondary Outcome Measure Information:
    Title
    objective measurement of rumination / supra-gastric belching, using high resolution impedance manometry monitoring
    Description
    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.
    Time Frame
    2 weeks treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    29206813
    Citation
    Pauwels A, Broers C, Van Houtte B, Rommel N, Vanuytsel T, Tack J. A Randomized Double-Blind, Placebo-Controlled, Cross-Over Study Using Baclofen in the Treatment of Rumination Syndrome. Am J Gastroenterol. 2018 Jan;113(1):97-104. doi: 10.1038/ajg.2017.441. Epub 2017 Dec 5.
    Results Reference
    derived

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    Baclofen for Rumination

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