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

Adnan Imtiaj Rahul

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: GERD - PPI Non-responders

Treatments: Drug: Placebo; Drug: Baclofen 10mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07063576

IRB-DMC/2025/70

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Baclofen

Active Comparator group

Description:

Tablet baclofen 10mg three times will be given along with conventional treatment

Treatment:

Drug: Baclofen 10mg

Placebo

Placebo Comparator group

Description:

Tablet placebo three times daily along with conventional treatment

Treatment:

Drug: Placebo