CTRI/2013/04/003538招募中3 期
A Multi-Center, Double Blind, Placebo-Controlled, Randomized, Parallel-GroupStudy To Evaluate The Safety And Clinical Equivalence of a Generic SucralfateOral Suspension, 1g/10ml (Hi-Tech Pharmacal Co., Inc., USA) To Carafate®Suspension, 1g/10ml (Aptalis Pharma, Inc., [Formerly Axcan Pharma US, Inc.,USA]) in the Treatment of Active Duodenal Ulcer Disease
HiTech Pharmacal Co Inc30 个研究点 分布在 1 个国家目标入组 575 人开始时间: 2013年10月4日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 575
- 试验地点
- 30
- 主要终点
- demonstrating upper gastro intestinal endoscopically assessed Duodenal ulcer healing
研究概览
简要总结
This is a multicentre, randomized, double-blind, prospective, placebo controlled, three arm, parallel group comparison trial, evaluating the clinical bioequivalence of generic sucralfate oral suspension, 1g/10 mL with Carafate® suspension in patients with duodenal ulcer. The primary endpoint is the percentage of patients with endoscopically assessed DU healing after 56 ± 2 days of treatment (approximately 8 weeks); the secondary endpoints include percentage of patients with endoscopically assessed DU healing after 28 ± 2 days of treatment (approximately 4 Weeks), the use of antacid rescue medication, ulcer pain scores and occurrence of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient must have endoscopically confirmed active duodenal ulcer of at least 3 mm in diameter and not exceeding 25 mm.
- •Patients must be confirmed H.pylori negative.
- •Willingness to continue with current (baseline) behavior with respect to diet, smoking, alcohol and caffeine consumption throughout the study.
- •Patient must sign an IRB/IEC-approved written Informed Consent Form (ICF), which includes agreement to comply with all study requirements as indicated in the protocol, including a negative urine pregnancy test at time of entry (if a female of child-bearing potential).
排除标准
- •Regular use of therapeutic dose of any non-steroidal anti-inflammatory drug (NSAID) during the study period or within 8 weeks prior to the baseline endoscopy.
- •Presence of 1 or more chronic ulcers.
- •Patients with more than two duodenal ulcers.
- •Patients whose ulcer is due to other diseases (e.g. Zollinger-Ellison Syndrome).
- •Patients with esophageal or gastric ulcers, or with active bleeding.
- •Patients being treated with an H2 receptor antagonist, prostaglandin, antacids, proton pump inhibitors, or any other anti-ulcer medication.
- •Requirement for continuing treatment with tetracyclines, or antimicrobial agents.
- •Use of any investigational agent within 30 days of the first dose of study medication.
- •Patients who have undergone previous gastric surgery, or who have previously experienced a perforated ulcer.
- •Bleeding ulcer or a history of a bleeding ulcer within 1 year prior to enrollment.
- •Presence of malignant lesions.
- •Significant and uncontrolled hepatic, cardiac, renal, or endocrine dysfunction.
- •A baseline serum aluminum concentration above upper limit of the normal range in the presence of abnormal renal function or an aluminum concentration at baseline that is greater than 2.5 times the upper limit of the normal range in a patient with normal renal function.
- •Patients who have undergone major trauma or surgery within the previous four weeks or patients scheduled to undergo surgery during the period of time covered by the study.
- •History of alcoholism or drug abuse in the 2 years prior to the study.
- •Any significant medical disorder that in the opinion of investigator, would preclude accurate evaluation of the patient’s condition.
- •Females who are pregnant or lactating or planning pregnancy during the study.
结局指标
主要结局
demonstrating upper gastro intestinal endoscopically assessed Duodenal ulcer healing
时间窗: [28 days], [56 days]
次要结局
- 1. The proportion of patients with endoscopically assessed DU healing after 28 ± 2 days of treatment(28 days)
- 2. Ulcer pain, as evaluated by a 100 mm Visual Analog Scale (VAS) at each Visit(Week 2, Week 4, Week 6 and Week 8)
- 3. Ulcer pain, as evaluated by daily pain scores(Week 2, Week 4, Week 6 and Week 8)
- 4. The use of antacid rescue medication(Week 2, Week 4, Week 6 and Week 8)
研究者
研究点 (30)
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