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New treatment option for GERD - PPI Non-responders
Official title Effect of Baclofen in Management of Patients With Gastroesophageal Reflux Disease Symptoms
ClinicalTrials.gov ID: NCT07063576
What this study is testing
What is Baclofen 10mg?
Baclofen 10mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for gerd - ppi non-responders.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 and above
- Patients with persistent GERD symptoms (Heart burn and/or regurgitation) despite taking conventional treatment including PPI for 8 weeks
You likely can't join if
- 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
See the full eligibility criteria
- Age 18 and above
- Patients with persistent GERD symptoms (Heart burn and/or regurgitation) despite taking conventional treatment including PPI for 8 weeks
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Dhaka, Bangladesh
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dhaka, Bangladesh. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.