A parallel, randomized, comparative, double-blind, double-dummy Placebo controlled clinical trial to evaluate the efficacy and safety of Lafutidine versus Rabeprazole in the Treatment of Acid Peptic Disease.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1. Proportion of patients with more than or equal to 50% improvement in baseline symptom severity. 2. Proportion of patients reporting a maximal allowable score of 20 on the VAS Scale for the clinical symptoms evaluated. 3. Proportion of patients reporting a change in the ulcer stage based on the endoscopic examinations. 4. Reduction in the size of the ulcer. 5. Resolution of other endoscopic findings of gastritis and/or peptic ulcers defined as a score of 2 or less for erosions.
研究概览
简要总结
It is a prospective parallel randomized, double-blind, double-dummy placebo controlled clinical trial. Patients with clinical signs and symptoms of Acid Peptic Disease, confirmed with diagnosis by endoscopy for the presence of gastritis and/or peptic ulcer disease will be enrolled in the study. The study will comprise of two arms: one comprising of patients with gastritis and the other of patients with peptic ulcer. 50 patients will be enrolled in each arm who will receive treatment with either lafutidine or Rabeprazole, as per randomization. A total of 100 patients will be enrolled in the study, where out of 50 patients of first arm, suffering from peptic ulcer, 25 patients shall receive lafutidine and remaining 25 shall receive Rabeprazole. In the second arm, out of 50 Patients suffering from gastritis, 25 shall receive lafutidine and the remaining 25 shall receive Rabeprazole. Patients will be screened prior to enrollment and eligibility will be assessed according to the specified inclusion and exclusion criteria.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female patients aged 18 years or older.
- •2.Clinical signs and symptoms of Acid peptic disease with endoscopic diagnosis of gastric mucosal injury (erosion/ oozing/redness/edema) as in gastritis (acute or acute exacerbation of chronic gastritis) and/or peptic ulcers (Patients with endoscopically diagnosed A1- or A2-stage ulcer (by Sakita/Miwa classification).
- •3.Patients willing to give written informed consent and willing to comply with trial protocol.
- •4.Patients who are on therapy with PPI, H2RAs, NSAIDs, muscarinic antagonists or other gastroprotective agents, but who have undergone a washout period of 7 days wherein only oral antacids are taken.
排除标准
- •1.Patients with a known history of hypersensitivity to study medications (rash, fever, itching, etc).2.Patients who had been treated with drugs capable of interfering with digestive mucosal integrity, gastric secretion or gastrointestinal motility, including H2 receptor antagonists, NSAIDs, muscarinic antagonists, gastroprotective agents (within the previous 7 days).3.Patients with history of pathological conditions of the intestine including inflammatory bowel disease/malabsorption syndromes/gastrointestinal malignancy/gastric or intestinal surgery including vagotomy/ Barrett's esophagus/ scleroderma.4.Patients showing alarm features (unintentional weight loss, persistent vomiting, dysphagia, haematemesis, melaena, fever, jaundice, or anaemia), or serious concomitant disease.5.Patients with signs of significant/massive GI bleeding.6.Patients who are unsuitable for pharmacotherapy e.g., with GI perforation or pyloric stenosis/esophageal stricture/intestinal obstruction.7.The presence of major hematological, renal, cardiac, pulmonary, or hepatic abnormalities.8.Patients who are pregnant, possibly pregnant, lactating, or who desire to become pregnant during the study.9.Patients who had previously been included or who had participated in any other clinical trial within the last 2 month.
- •10.Patients who are drug or alcohol abusers or suffering from any other condition associated with poor compliance.
- •11.Patients who are otherwise judged inappropriate for inclusion in the study by the investigator.
结局指标
主要结局
1. Proportion of patients with more than or equal to 50% improvement in baseline symptom severity. 2. Proportion of patients reporting a maximal allowable score of 20 on the VAS Scale for the clinical symptoms evaluated. 3. Proportion of patients reporting a change in the ulcer stage based on the endoscopic examinations. 4. Reduction in the size of the ulcer. 5. Resolution of other endoscopic findings of gastritis and/or peptic ulcers defined as a score of 2 or less for erosions.
时间窗: baseline, day 14 and day 28
次要结局
- 1. Sustained clinical symptom relief defined as the absence of the clinical symptom evaluated in the previous 7 days. 2. Cure of peptic ulcer based on endoscopic findings.(3. Cure of gastritis and/or peptic ulcers based on the endoscopic examinations. 4. Patient and Investigator assessment of efficacy and tolerance.)