A prospective, comparative, controlled, randomized, open label, parallel, 3-arm study to evaluate and compare the efficacy and safety of Troxipide (100 mg) and Rabeprazole (20 mg) alone and in combination in patients suffering from acid peptic disorders
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- • Proportion of patients with improvement of symptoms severity score
研究概览
简要总结
Acid pepticdisorders (APD) is a collective term occuring typically as consequence of either hypersecretionof acid / pepsin or normal acid effect on diminished mucosal defence or both. APD is one of the most frequent reasons formedical consultation in Asian countries and has highly prevalence among theAsian population.
APD though being a heterogeneous pathological condition, commonlypresents will similar cluster of symptoms including Postprandial fullness,Early satiety, Bloating, Epigastric discomfort (poorly localized), Epigastricpain (a sharp, easy to pinpoint), Postprandial nausea, Belching after meals, Vomitingnow collectively termed as Dyspepsia. The frequency of medicalvisits for dyspepsia has been found to increase with increasing ageand with increasing severity of dyspeptic symptoms.
As majority of the patients seek medical care only after the disease-relatedsymptoms become more frequent or more severe, the current drugtreatment is targeted towards symptomatic relief usually using empiricalacid-suppressive therapy (PPI, H2 blockers, antacids) in primary care. Protonpump inhibitors (PPIs) are the most effective class of acid suppression agents providing maximum relief from dyspeptic symptoms. Rabeprazoleis PPI with a faster onset of action and faster symptom control and also aidin gastric mucin synthesis. Since,APD is end result of an imbalance between mucosaldefensive and aggressive factors a great deal of attention has been focusedon role of the cytoprotective agents in strengthening the mucosal defensivefactors. Troxipideis a new gastric cytoprotective agent with antiulcer, anti-inflammatory andmucus secreting properties. Though the exact mechanism of action of Troxipide is notfully elucidated, it has been clinically proven to heal gastritisand gastric ulcers. Cytoprotectionand Acid suppression being two limbs of the etiopathology of Acid pepticdisorders, drugs acting on both limbs may prove to be a potential synergism inoutcome of the disease. This clinical study is hence been conducted to comparethe relative efficacy of a cytoprotective agent, Troxipide; as monotherapy andin combination with an acid suppressive agent, Rabeprazole; in alleviating the symptoms of Acid Peptic Disorders againstthe currently followed treatment modalityof acid suppression with proton pump inhibitors
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Patients with symptoms of dyspepsia having Glasgow Dyspepsia Severity Score > 2 OR • Patients undergoing upper gastro intestinal endoscopy having signs of any of acid peptic disorder AND • Subjects who provide a written informed consent.
排除标准
- •â€¢ History of any diagnosed gastrointestinal disorder other than acid peptic disorder • History of any previous abdominal / gastrointestinal surgery • History of treatment with drugs capable of interfering with digestive mucosal integrity, acid secretion or gastrointestinal motility, (including H2 receptor antagonists, NSAIDs, muscarinic antagonists, cytoprotective agents) within the previous 7 daysys • Requires concomitant medication which precludes the evaluation of study medications • Patients with signs suggestive of any acute complication of acid peptic disorder • Any contraindication for endoscopy examination • Evidence of gastric malignancy, pyloric obstruction, or oesophageal stricture on endoscopy • Patients who are drug or alcohol abusers • Patients with known hypersensitivity to any of the ingredients of the test / Comparator formulation • Patients with impairment of renal or hepatic function, severe cardiac disease, any respiratory disease or haematological abnormality • Pregnant or lactating females • Simultaneous participation in another clinical study 30 days prior to the study.
结局指标
主要结局
• Proportion of patients with improvement of symptoms severity score
时间窗: • Symptom score: Day 0, Day 14, Day 28 | • Endoscopic Evaluation: Day 0, Day 28
• Proportion of patients with improvement on endoscopic evaluation
时间窗: • Symptom score: Day 0, Day 14, Day 28 | • Endoscopic Evaluation: Day 0, Day 28
次要结局
- • Symptom severity Sub scores(Day 0, Day 14, Day 28)
- • Incidence of Rescue medication use(Day 28)
- • Global assessment of efficacy and tolerance by investigator at end of treatment(Day 0, Day 28)
- • Adverse event frequency and severity(As and when it occurs)
- • Laboratory Investigations for safety assessment(Day 0, Day 28)