Back to resultsA Placebo Controlled Trial With Baclofen for the Treatment of GERD Patients With Incomplete PPI Response
Primary Purpose
Gastro Esophageal Reflux
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Baclofen
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Gastro Esophageal Reflux
Eligibility Criteria
Inclusion Criteria:
- 18 - 75 years old
- History of typical (heartburn/regurgitation) or atypical GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks. Daily intake of PPI treatment 12 weeks prior to inclusion.
- 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.
- 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:
- Endoscopic signs of severe erosive esophagitis (≥ grade C, Los Angeles classification) on endoscopy performed during PPI treatment in the 6 months prior to screening.
- 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.
- Regular use of medications such as: anticholinergics, tricycle antidepressants.
- Significant neurological, respiratory, hepatic, renal, haematological, cardiovascular, metabolic or gastroinestinal cerebrovascular disease as judged by the investigator
- Absence of PPI intake for at least 2 consecutive days in the 2 weeks prior to the screening.
- 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-compensated 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
Active Comparator
Placebo Comparator
Arm Label
baclofen arm
placebos arm
Arm Description
baclofen 10mg tid for 4 weeks
placebo tid for 4 weeks
Outcomes
Primary Outcome Measures
efficacy of baclofen on reflux symptom questionnaire
To assess the effect of baclofen on reflux symptom questionnaire by ReQuest
efficacy of baclofen on pH-impedance recordings
To assess of baclofen on 24 hour pH-impedance recordings
Secondary Outcome Measures
Predictive value of the reflux monitoring
To assess the predictive value of the 24 hour pH-impedance monitoring (symptom association probability = SAP) on the primary outcome
Full Information
NCT ID
NCT03835442
First Posted
February 4, 2019
Last Updated
February 7, 2019
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT03835442
Brief Title
A Placebo Controlled Trial With Baclofen for the Treatment of GERD Patients With Incomplete PPI Response
Official Title
A Placebo Controlled Trial With Baclofen for the Treatment of GERD Patients With Incomplete PPI Response
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 2010 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2019 (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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Reflux (acid and non-acid) mainly occurs during transient LES relaxations (TLESRs). The gamma-aminobutyric acid (GABA) receptor type B agonist baclofen was shown to inhibit TLESRs, thereby significantly decreasing acid reflux after a meal in healthy controls and in patients with GERD.
The primary objective of this study is to assess the efficacy (assessed by reflux symptom questionnaire and pH-impedance recordings) of baclofen 10mg three times daily vs. placebo in GERD patients with an incomplete response to PPI therapy.
The secondary objective is to assess the predictive value of reflux assessment (by pH-impedance recordings) on the primary outcome.
Detailed Description
This is a randomized, parallel, double-blind, placebo-controlled, out-patient, single-center study. Eligible subjects will be randomly assigned to receive either oral baclofen 10 mg or placebo t.i.d for a period 4 weeks. After 4 weeks all patients will be given the standard dose of baclofen 10 mg t.i.d. (open label), for another 4 weeks. The b.i.d. PPI therapy will be continued for the entire study duration.
Approximately 90 evaluable subjects with typical GERD symptoms (heartburn and/or regurgitation) will participate in this study and will be randomized on a 1:1 basis: 45 subjects each will be in the placebo and baclofen 10 mg three times daily group. Subjects will be considered to have completed the study if they complete the week 4 visit.
Medication will consist of identically-looking capsules of baclofen or placebo. Patients will take 1 capsule containing 5 mg baclofen with meals t.i.d for 7 days and then 1 capsule containing 10 mg baclofen with meals t.i.d for the remaining 21 days.
Prior to visit 1, all subjects included in the study will undergo a 24 hr pH-impedance study which was requested by the treating physician. This investigation is part of the standard clinical work up and will not be part of the study protocol.
Informed consent is to be signed and dated by the subject before any study related procedures are performed. The date of each visit to the clinic and the date and time of the last dose of test article will be recorded.
Throughout the study patients will be asked to complete daily a short questionnaire (ReQuest) for reflux symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro Esophageal Reflux
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, parallel, double-blind, placebo-controlled, out-patient, single-center study
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
baclofen arm
Arm Type
Active Comparator
Arm Description
baclofen 10mg tid for 4 weeks
Arm Title
placebos arm
Arm Type
Placebo Comparator
Arm Description
placebo tid for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Baclofen
Other Intervention Name(s)
Lioresal
Intervention Description
baclofen 10mg tid for 4 weeks
Intervention Type
Other
Intervention Name(s)
Placebos
Intervention Description
placebo tid for 4 weeks
Primary Outcome Measure Information:
Title
efficacy of baclofen on reflux symptom questionnaire
Description
To assess the effect of baclofen on reflux symptom questionnaire by ReQuest
Time Frame
Change from baseline in ReQuest scores at 4 weeks
Title
efficacy of baclofen on pH-impedance recordings
Description
To assess of baclofen on 24 hour pH-impedance recordings
Time Frame
Change from baseline in reflux parameters (total number of reflux episodes) on 24h pH-impedance monitoring at 4 weeks
Secondary Outcome Measure Information:
Title
Predictive value of the reflux monitoring
Description
To assess the predictive value of the 24 hour pH-impedance monitoring (symptom association probability = SAP) on the primary outcome
Time Frame
Is SAP at baseline predictor of response at 4 weeks
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:
18 - 75 years old
History of typical (heartburn/regurgitation) or atypical GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks. Daily intake of PPI treatment 12 weeks prior to inclusion.
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.
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:
Endoscopic signs of severe erosive esophagitis (≥ grade C, Los Angeles classification) on endoscopy performed during PPI treatment in the 6 months prior to screening.
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.
Regular use of medications such as: anticholinergics, tricycle antidepressants.
Significant neurological, respiratory, hepatic, renal, haematological, cardiovascular, metabolic or gastroinestinal cerebrovascular disease as judged by the investigator
Absence of PPI intake for at least 2 consecutive days in the 2 weeks prior to the screening.
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-compensated depression is allowed).
History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Tack, PhD, MD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Placebo Controlled Trial With Baclofen for the Treatment of GERD Patients With Incomplete PPI Response
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