Effect of Baclofen as an Add on Therapy in Management of Patients With Gastroesophageal Reflux Disease Symptoms
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Improvement of GERD symptoms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and above
- •Patients with persistent GERD symptoms (Heart burn and/or regurgitation) despite taking conventional treatment including PPI for 8 weeks
排除标准
- •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
研究组 & 干预措施
Baclofen
Tablet baclofen 10mg three times will be given along with conventional treatment
干预措施: Baclofen 10mg (Drug)
Placebo
Tablet placebo three times daily along with conventional treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement of GERD symptoms
时间窗: At baseline before randomization and at week 4
The improvement of GERD symptoms will be assessed by GERD Q questionnaire.
次要结局
- Effect of baclofen along with conventional treatment(At week 4)
- Effect of placebo along with conventional treatment(At 4 week)
- Comparison of effects of baclofen and placebo along with conventional treatment(At week 4)
- Adverse events(Through the completion of study approximately one year)
研究者
Adnan Imtiaj Rahul
Principal investigator
Dhaka Medical College