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A Placebo Controlled Trial With Baclofen for the Treatment of GERD Patients With Incomplete PPI Response

NCT03835442 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-02-08

No results posted yet for this study

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.

Conditions

  • Gastro Esophageal Reflux

Interventions

DRUG

Baclofen

baclofen 10mg tid for 4 weeks

OTHER

Placebos

placebo tid for 4 weeks

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Jan Tack, PhD, MD · UZ Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2016-12-31
Completion
2019-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03835442 on ClinicalTrials.gov