Baclofen Impact on Gastroesophageal Reflux Disease Symptoms Management
This study is evaluating how well baclofen treats symptoms of Gastroesophageal Reflux Disease (GERD) in adults, phase 2 treatment trial.
Baclofen 10mg
+ Placebo
Treatment Study
Summary
Study start date: August 1, 2025
Actual date on which the first participant was enrolled.This clinical trial is exploring how adding the drug baclofen to the usual treatment might help people with symptoms of Gastroesophageal Reflux Disease (GERD). GERD is a condition where stomach acid frequently flows back into the tube connecting the mouth and stomach, causing discomfort and other symptoms. The study is important because it seeks to determine whether baclofen can provide additional relief from these symptoms and improve the quality of life for those affected. It also aims to ensure that using baclofen is safe by keeping track of any side effects experienced by participants. Participants in the study will either receive baclofen or a placebo, in addition to their regular treatment, for a period of four weeks. They will take 10 milligrams of baclofen or the placebo three times a day. At the end of the study period, participants will visit the hospital for an assessment. Their GERD symptoms will be evaluated using a specific questionnaire both at the start and after four weeks to see if there is any improvement. Additionally, any side effects reported by participants will be recorded to assess the safety of baclofen.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location