Phase III of the AB Prep Safety and Efficacy in Colon Cleansing
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- TOTAL COLON CLEANSING, TO BE ABLE TO PERFORM COLONOSCOPY
研究概览
简要总结
The purpose of this study is determine if the AB Prep (a 16 tablets colon cleansing prep), is an effective, and safe colon cleansing prep in preparation for colonoscopy, and severe constipation.
详细描述
The available colon cleansing preps have issues with patient's tolerance( Abdominal pain, nausea, vomiting), and as recently noted by the FDA safety issues such a change in EKG, blood electrolytes requiring 72 hours to correct, and most recently PO4 nephropathy.
The AB Prep is a 16 tablets prep that has excellent patient's tolerance efficacy, with no change in blood electrolytes or EKG. ( PhaseI (20 patients) and Phase II (200 patients)
The protocol that was used is as follows:
(IND application # 75,704)
Protocol design for testing the safety and efficacy of the AB Prep:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any eligible patient for colonoscopy
排除标准
- •Patients with renal failure
研究组 & 干预措施
PREVENTION AND TREATMENT
PATIENTS 50 YEARS AND OLDER REQUIRE SCREENING COLONOSCOPY. PATIENTS WITH FAMILY HISTORY OF COLON CANCER WILL REQUIRE IT BEFORE THE AGE OF 50.
干预措施: AB PREP (Drug)
结局指标
主要结局
TOTAL COLON CLEANSING, TO BE ABLE TO PERFORM COLONOSCOPY
时间窗: IMMEDIATE, DURING THE COLONOSCOPY
次要结局
未报告次要终点