A randomized, double blind, double dummy, active controlled, parallel-group, multicenter, phase III study to compare the efficacy and safety of rabeprazole sodium 40 mg MR capsule once daily of Dr. Reddys Laboratories Limited with rabeprazole sodium 20 mg Enteric coated Tablet once daily in patients with erosive gastroesophageal reflux disease, refractory to standard PPI therapy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 286
- 试验地点
- 15
- 主要终点
- To evaluate the efficacy of Rabeprazole 40 mg MR capsule in comparison to Rabeprazole 20 mg Enteric coated tablet in
研究概览
简要总结
Gastroesophageal reflux disease (GERD), the most common gastrointestinal (GI) disorder, observed by gastroenterologists, surgeons, and primary care physicians. GERD is defined as symptoms or lesions that result from the retrograde flow of gastric contents into the esophagus.1 Proton pump inhibitors (PPIs), after acid activation to sulfonamides, covalently bind to cysteine residues on the luminal surface of H+/K+ ATPase proton pumps in the parietal cells, blocking ion transport andacid secretion Although PPIs are currently the most effective treatment for GERD and its complications.1,3 Patients with continued symptoms despite PPI treatment are considered to have refractory GERD. Up to 30% of GERD patients experience refractory GERD.4 Up to 40% of patients with non-erosive reflux disease (NERD) remain symptomatic on standard therapy, and approximately 10–15% of patients with erosive esophagitis (EE) do not achieve full remission after 8 weeks of treatment.
Multiple factors are likely to explain these treatment failures, in an attempt to improve acid suppression of PPIs, clinicians have given larger single doses or administered the drugs multiple times a day. Both delayed release (DR) & immediate release (IR) PPIs have relatively rapid delivery of drugs in the small intestine for absorption into systemic circulation and equally rapid elimination process through combination of hepatic metabolism & renal excretion
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Males and females aged between 18 and 65 years both inclusive 2 Subject diagnosed with endoscopically confirmed erosive GERD and experiencing GERD symptoms heartburn or regurgitation on more than 4 days per week for at least 4 weeks prior to screening visit.
- •Los Angeles (LA) Classification System for erosive Esophagitis to be used 3 Subjects on once daily Proton Pump Inhibitors for at least 8 weeks prior to screening 4 Subjects without any organic GI tract pathology based on upper GI endoscopy 5 Subjects willing to provide written informed consent and willing to comply with study instructions for its duration 6 Female subjects of child-bearing potential should have negative serum pregnancy test at screening and agree to use adequate birth control during the entire study period OR Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study subject).
- •OR Postmenopausal for at least 1 year.
排除标准
- •1History of hypersensitivity or allergy to any of the study drugs or it components 2.subjects with presence of alarming symptoms for probable malignancy( eg weight loss greater than 5% in the last 60 days persistent vomiting progressive dysphagia orodynophagia.
结局指标
主要结局
To evaluate the efficacy of Rabeprazole 40 mg MR capsule in comparison to Rabeprazole 20 mg Enteric coated tablet in
时间窗: 4 weeks , 8 weeks
patients with erosive Gastroesophageal Reflux Disease, Symptomatic despite receiving standard once daily PPI for at least 8 weeks prior to randomization
时间窗: 4 weeks , 8 weeks
次要结局
- To evaluate the safety and efficacy of Rabeprazole 40 mg MR(capsule in comparison to Rabeprazole 20 mg Enteric Coated)
研究者
Dr Piyush Agarwal
Dr Reddys Laboratories Ltd