Effect of Baclofen in Management of Patients With Gastroesophageal Reflux Disease Symptoms

Phase 3RecruitingNCT07063576

Adnan Imtiaj Rahul60 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

GERD - PPI Non-responders

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Improvement of GERD symptoms

The improvement of GERD symptoms will be assessed by GERD Q questionnaire.

Time frame: At baseline before randomization and at week 4

Secondary Outcomes

Effect of baclofen along with conventional treatment

Effect of baclofen along with conventional treatment including PPI on GERD symptoms will be assessed by GERD Q questionnaire

Time frame: At week 4

Effect of placebo along with conventional treatment

Effect of placebo along with conventional treatment including PPI on GERD symptoms will be assessed by GERD Q questionnaire

Time frame: At 4 week

Comparison of effects of baclofen and placebo along with conventional treatment

Comparison of effects of baclofen and placebo along with conventional treatment including PPI on GERD symptoms will be assessed by GERD Q questionnaire

Time frame: At week 4

Adverse events

Patients reported adverse events will be documented

Time frame: Through the completion of study approximately one year