NCT00685607已完成4 期
A Placebo-Controlled, Double-Blind, Randomized Pilot Study to Evaluate the Appropriateness of Multiple Endpoints in Measuring the Onset of Clinical Efficacy of Loperamide-Simethicone Caplets in the Treatment of Acute Non-specific Diarrhea
Johnson & Johnson Consumer and Personal Products Worldwide1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2008年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Evaluate Multiple Endpoints
研究概览
简要总结
For six hours following drug administration, subjects will rate the severity of specific symptoms. At the end of the six hour study, subjects will rate the overall effectiveness of the product.
详细描述
A six-hour study to evaluate multiple early efficacy endpoints in loperamide-simethicone therapy to help identify speed of onset of symptomatic treatment of acute nonspecific diarrhea (ANSD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acute diarrhea with gas-related abdominal discomfort, meeting specific criteria
- •Willing to follow the protocol requirements and comply with protocol restrictions, including use of contraception
- •Able to understand the informed consent process and sign the form
- •Cooperative, reliable and willing to comply with the protocol requirements and schedule, and able to record efficacy and safety assessments.
排除标准
- •Female subjects who are pregnant, lactating or experiencing perimenstrual abdominal or pelvic discomfort
- •Illness requires hospitalization, IV fluids or antibiotics
- •Has taken antibiotics in the past 7 days or a symptomatic antidiarrheal compound in the past 12 hours or any analgesic in the past 6 hours
- •History of significant underlying enteric, pulmonary, hepatic, cardiac, renal disease, seizure disorder, IBD, cancer, uncontrolled diabetes, or any other unstable medical condition
- •History of hypersensitivity to loperamide or simethicone
- •Has previously participated in this study or received an investigational drug within the 30 day period before screening
研究组 & 干预措施
1
Experimental
loperamide-simethicone
干预措施: loperamide-simethicone (Drug)
2
Placebo Comparator
matching placebo
干预措施: matching placebo (Drug)
结局指标
主要结局
Evaluate Multiple Endpoints
时间窗: 6 hours
次要结局
- Time to improvement in gas-related abdominal discomfort(6 hours)
- Time to improvement in stool form(6 hours)
- Time to improvement in urge to defecate(6 hours)
- Time to improvement of change in normal activities of daily living(6 hours)
- Subject global impression of efficacy of study medication at the end of the treatment period(6 hours)
- Physical examination and vital signs at the screening visit and the monitoring of adverse events throughout the course of the study(6 hours)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
A Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Orvepitant in Subjects With Major Depressive DisorderDepressive DisorderNCT00880048GlaxoSmithKline343
已完成
3 期
Lurasidone Pediatric Autism StudyAutismNCT01911442Sumitomo Pharma America, Inc.150
已完成
2 期
ACP-104 in Acutely Psychotic Subjects With SchizophreniaSchizophreniaNCT00490516ACADIA Pharmaceuticals Inc.247
已完成
3 期
Study of the Efficacy of Lurasidone in Cognitive Functioning in Bipolar PatientsBipolar DisorderNCT02731612Lakshmi N Yatham100
已完成
2 期
Safety and Efficacy of Intranasal Ketamine for the Treatment of Postoperative Dental PainPain, PostoperativeNCT00488787Javelin Pharmaceuticals40