CTRI/2010/091/001057已完成4 期
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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
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.
研究者
相似试验
已完成
4 期
A Comparative Clinical trial to Evaluate the Efficacy and Tolerability of Troxipide in the treatment of gastritis and/or gastric ulcer disease.CTRI/2012/12/003264Zuventus Healthcare Ltd50
已完成
3 期
A clinical trial to study the effects of a combination of trypsin-chymotrypsin enzymes and diclofenac in comparison to diclofenac alone in patients with soft tissue injuries.CTRI/2009/091/000813Elder Pharmaceuticals Ltd.,C-9, Dalia Industrial Estate, Veera Desai Road, Off New Link Road,Andheri (W), Mumbai ? 53.
尚未招募
不适用
In patients suffering from acute or chronic Rhino-sinusitisCTRI/2017/03/008016VITROBIO63
尚未招募
不适用
Clinical Trial Study to Evaluate Efficacy and Safety of a Filmogen Glycerol Throat Spray containing CW-CYANIDIN Plant PremixCTRI/2016/09/007265VITROBIO63
进行中（未招募）
不适用
A randomised, double-blind, double-dummy, parallel-group multicenter study to demonstrate improvement in symptoms of constipation in subjects with non-malignant pain taking oxycodone equivalent of 60 - 80 mg/day as oxycodone / naloxone prolonged release (OXN) compared to subjects taking oxycodone prolonged release tablets alone.Moderate to severe chronic non-malignant pain that requires around-the-clock opioid therapy and also constipation secondary to opioid treatment.MedDRA version: 7.1Level: ptClassification code 10003988EUCTR2005-003510-15-HUMundipharma Research GmbH & Co. KG480