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

NCT03835442 | Completed

• 1 other identifier: S51996
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastro Esophageal Reflux

Outcome Measures

Primary Outcomes (2)

• efficacy of baclofen on reflux symptom questionnaire

  To assess the effect of baclofen on reflux symptom questionnaire by ReQuest

  Change from baseline in ReQuest scores at 4 weeks

• efficacy of baclofen on pH-impedance recordings

  To assess of baclofen on 24 hour pH-impedance recordings

  Change from baseline in reflux parameters (total number of reflux episodes) on 24h pH-impedance monitoring at 4 weeks

Secondary Outcomes (1)

• Predictive value of the reflux monitoring

  Is SAP at baseline predictor of response at 4 weeks

Study Arms (2)

baclofen arm

ACTIVE COMPARATOR

baclofen 10mg tid for 4 weeks

Drug: Baclofen

placebos arm

PLACEBO COMPARATOR

placebo tid for 4 weeks

Other: Placebos

Interventions

Baclofen DRUG

baclofen 10mg tid for 4 weeks

Also known as: Lioresal

baclofen arm

Placebos OTHER

placebo tid for 4 weeks

placebos arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Jan Tack, PhD, MD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: randomized, parallel, double-blind, placebo-controlled, out-patient, single-center study

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 8, 2019
• Study Start: January 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2019
• Last Updated: February 8, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share