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

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

Recruiting
18 years and older
All
Phase 2/3

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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.

Eligibility

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

Study details
    GERD - PPI Non-responders

NCT07063576

Adnan Imtiaj Rahul

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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