Status:
COMPLETED
A Placebo Controlled Trial With Baclofen for the Treatment of GERD Patients With Incomplete PPI Response
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Gastro Esophageal Reflux
Eligibility:
All Genders
18-75 years
Phase:
NA
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 significant...
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 f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03835442
Start Date
January 1 2010
End Date
January 1 2019
Last Update
February 8 2019
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