Effect of Baclofen in Management of Patients With Gastroesophageal Reflux Disease Symptoms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Baclofen 10mg, Placebo.
- Who it may be relevant to
- Registry conditions: GERD - PPI Non-responders. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bangladesh
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Baclofen as an Add on Therapy in Management of Patients With Gastroesophageal Reflux Disease Symptoms
Overview
The goal of this clinical trial is to assess the effect of using baclofen along with conventional treatment in improving GERD symptoms. It will also assess the safety of drug baclofen by recording the patient reported adverse events. The main questions it aims to answer are : Does drug baclofen along with conventional treatment has any effect on patients with GERD symptoms? What medical problems do participants have when taking drug baclofen? Researcher will compare drug baclofen along with conventional treatment to a control group taking placebo along with conventional treatment. Participants will: Take drug baclofen 10 milligrams or placebo three times daily along with conventional treatment for 4 weeks. They will visit the hospital after 4 weeks. Their symptoms will be assessed via validated GERD Q questionnaire at baseline and after 4 weeks. Additionally, patient reported adverse events will be documented.
Interventions
- Drug Baclofen 10mg
Tablet baclofen 10mg three times daily along with conventional treatment - Drug Placebo
Tablet placebo three times daily along with conventional treatment
Primary outcome measures
- Improvement of GERD symptoms [Time frame: At baseline before randomization and at week 4]
Secondary outcome measures (4)
- Effect of baclofen along with conventional treatment [Time frame: At week 4]
- Effect of placebo along with conventional treatment [Time frame: At 4 week]
- Comparison of effects of baclofen and placebo along with conventional treatment [Time frame: At week 4]
- Adverse events [Time frame: Through the completion of study approximately one year]
Eligibility criteria
Inclusion criteria
- Age 18 and above
- Patients with persistent GERD symptoms (Heart burn and/or regurgitation) despite taking conventional treatment including PPI for 8 weeks
Exclusion criteria
- GERD symptoms with any alarming features (dysphagia, weight loss, bleeding, vomiting, and/or anemia)
- Baseline GERD Q score less than 8
- Peptic gastric or duodenal ulcer on endoscopy
- Other esophageal disease like achalasia, carcinoma, corrosive stricture
- Gastrointestinal malignancy
- History of major gastrointestinal surgery
- Medical disease that affects the esophageal or gastric motility, such as uncontrolled diabetes, hyperthyroidism, hypothyroidism
- Patient with renal impairment
- Pregnant and lactating women
- Use of drugs affecting on LES
- Regular use of drug that may interact with Baclofen
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Bangladesh · 1 center
- Dhaka Medical College — Dhaka
Identifiers
NCT: NCT07063576 · IRB-DMC/2025/70