GERD - PPI Non-responders
Conditions
Keywords
baclofen, GERD symptoms
Brief summary
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
DRUGBaclofen 10mg
Tablet baclofen 10mg three times daily along with conventional treatment
DRUGPlacebo
Tablet placebo three times daily along with conventional treatment
Sponsors
Adnan Imtiaj Rahul
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of GERD symptoms | At baseline before randomization and at week 4 | The improvement of GERD symptoms will be assessed by GERD Q questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of baclofen along with conventional treatment | At week 4 | Effect of baclofen along with conventional treatment including PPI on GERD symptoms will be assessed by GERD Q questionnaire |
| Effect of placebo along with conventional treatment | At 4 week | Effect of placebo along with conventional treatment including PPI on GERD symptoms will be assessed by GERD Q questionnaire |
| Comparison of effects of baclofen and placebo along with conventional treatment | At week 4 | Comparison of effects of baclofen and placebo along with conventional treatment including PPI on GERD symptoms will be assessed by GERD Q questionnaire |
| Adverse events | Through the completion of study approximately one year | Patients reported adverse events will be documented |
Countries
Bangladesh
Contacts
Primary ContactAdnan Imtiaj Rahul, MBBS
Outcome results
None listed