Effect of Methylnaltrexone on Gastrointestinal and Colonic Transit in Health
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Colonic Geometric Center at 24 Hours
研究概览
简要总结
This is a single-center, randomized, double blind, placebo-controlled study evaluating the effects of placebo, codeine, methylnaltrexone and codeine with methylnaltrexone on gastrointestinal motility and colonic transit of solids in healthy human subjects.
The hypotheses are:
- Methylnaltrexone administered subcutaneously enhances gastrointestinal motility with acceleration of overall colonic transit, and ascending colon emptying of solids in healthy humans.
- Methylnaltrexone significantly accelerates colonic transit that is delayed by codeine
详细描述
Methodology
Following the initial screening visit (visit 1), participants will be randomized to study medication, either 0.30mg/kg methylnaltrexone subcutaneously or placebo once daily and 30 mg codeine orally or placebo taken four times daily for a total of five days. Participants will be randomly assigned to study medication and allocation will be concealed. A urine pregnancy test will be performed for all females of child bearing potential within the 48 hours prior to the receipt of study medication. Note that females who are status post bilateral tubal ligation, hysterectomy or postmenopausal are exempted from this test. Study medication will be administered on study med days 1, 2 and 3 (visits 2, 3 and 4) at the Clinical Research Unit (CRU). Participants will return for scintigraphic assessment of gastric, small bowel and colonic transit of solids on study med days 4 and 5 (visits 5 and 6). The transit studies will be undertaken on over a 48 hour time period; no study medication is given on the final day of transit (visit 7).
Investigational product, dosage, mode of administration, duration of treatment
0.30 mg/kg methylnaltrexone or placebo subcutaneously once daily and 30 mg codeine or placebo orally four times daily for five consecutive days.
Treatment groups
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Methylnaltrexone
干预措施: Methylnaltrexone only (Drug)
Codeine
干预措施: Codeine only (Drug)
Methylnaltrexone + codeine
干预措施: Methylnaltrexone + codeine (Drug)
Placebo
干预措施: Placebo + placebo (Drug)
结局指标
主要结局
Colonic Geometric Center at 24 Hours
时间窗: 24 hours
The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
次要结局
- Stool Frequency(daily)
- T1/2 of Gastric Emptying of Solid(4 hours)
- Colonic Filling at 6 Hours(6 hours)
- T1/2 of Ascending Colon Emptying(24 hours)
- Colonic Geometric Center at 4 Hours(4 hours)
- Colonic Geometric Center at 48 Hours(48 hours)
- Stool Consistency as Reported From the Bristol Stool Scale(Daily)