Localized Therapeutics for the Treatment of Gastrointestinal Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Patient preference, as assessed by questionnaire
研究概览
简要总结
The purpose of this study is to determine the patient preference for a biocompatible thermosensitive solution-gel versus water or saline (liquid) enema. The thermosensitive solution-gel is comprised of poloxamer, an inactive compound that is designated as GRAS (generally recognized as safe) by FDA. It could subsequently be used as a medium for drug delivery. The poloxamer (gel) is administered to study participants in order to assess preference and proximal distribution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally healthy
- •Age 18 to 70 years old
- •Non-pregnant
排除标准
- •GI complaints
- •Pregnancy
- •Patients with previous colonic surgery or current bowel injury or obstruction
- •Allergies to contrast
研究组 & 干预措施
Thermosensitive gel formulation
Thermosensitive gel rectal formulation or saline (control) enema with crossover to the other.
干预措施: Thermosensitive gel rectal formulation (Other)
Thermosensitive gel formulation
Thermosensitive gel rectal formulation or saline (control) enema with crossover to the other.
干预措施: Saline enema (Other)
Saline enema
Thermosensitive gel rectal formulation or saline (control) enema with crossover to the other.
干预措施: Thermosensitive gel rectal formulation (Other)
Saline enema
Thermosensitive gel rectal formulation or saline (control) enema with crossover to the other.
干预措施: Saline enema (Other)
结局指标
主要结局
Patient preference, as assessed by questionnaire
时间窗: Up to 3 hours post-administration
次要结局
未报告次要终点
研究者
Sidhartha R Sinha
Principle Investigator
Stanford University