A Phase I Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of Naloxegol on Gastric, Small Bowel, and Colonic Transit in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Gastric emptying (t1/2)
研究概览
简要总结
This research study was being done to study the effect of codeine and Naloxegol for 3 days compared to placebo on the movement of food through the colon of healthy individuals. Codeine is a commonly used pain-relieving drug that often causes constipation as an unwanted side effect. Naloxegol is a medication recently approved by the FDA for treatment of constipation induced by Codeine.
The hypothesis for this study was that Naloxegol reduces the retardation of small bowel and colonic transit induced by codeine in healthy participants.
详细描述
This was a single center, randomized, double-blind, placebo-controlled, parallel-group, Phase I study of the effects of naloxegol, a novel mu-opioid antagonist, on gastrointestinal and colonic transit in the presence or absence of the mu-opiate, codeine. There is a need to develop effective medications for the treatment of opiate-induced constipation and other motility disorders. Currently available opiates are complicated by addictive potential and induction of troublesome constipation.
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
- Triple (Participant, 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
Codeine/naloxegol placebo
Each subject will receive two medications to which they are randomized for 1 day before and for the 2 days during transit measurement.
Codeine tablet 30 mg q.i.d., and placebo tablet matching naloxegol q.d.
干预措施: Codeine (Drug)
Codeine/naloxegol placebo
Each subject will receive two medications to which they are randomized for 1 day before and for the 2 days during transit measurement.
Codeine tablet 30 mg q.i.d., and placebo tablet matching naloxegol q.d.
干预措施: naloxegol placebo (Drug)
Naloxegol/ codeine placebo
Each subject will receive two medications to which they are randomized for 1 day before and for the 2 days during transit measurement.
Naloxegol tablet 25 mg q.d and placebo tablet matching codeine q.i.d.
干预措施: Naloxegol (Drug)
Naloxegol/ codeine placebo
Each subject will receive two medications to which they are randomized for 1 day before and for the 2 days during transit measurement.
Naloxegol tablet 25 mg q.d and placebo tablet matching codeine q.i.d.
干预措施: codeine placebo (Drug)
Codeine/ naloxegol
Each subject will receive two medications to which they are randomized for 1 day before and for the 2 days during transit measurement.
Codeine tablet 30 mg q.i.d., and naloxegol tablet 25 mg q.d.
干预措施: Naloxegol (Drug)
Codeine/ naloxegol
Each subject will receive two medications to which they are randomized for 1 day before and for the 2 days during transit measurement.
Codeine tablet 30 mg q.i.d., and naloxegol tablet 25 mg q.d.
干预措施: Codeine (Drug)
codeine placebo/ naloxegol placebo
Each subject will receive two medications to which they are randomized for 1 day before and for the 2 days during transit measurement.
Placebo tablet matching codeine q.i.d., and placebo tablet matching naloxegol q.d.
干预措施: codeine placebo (Drug)
codeine placebo/ naloxegol placebo
Each subject will receive two medications to which they are randomized for 1 day before and for the 2 days during transit measurement.
Placebo tablet matching codeine q.i.d., and placebo tablet matching naloxegol q.d.
干预措施: naloxegol placebo (Drug)
结局指标
主要结局
Gastric emptying (t1/2)
时间窗: Day 2
The time for half of the ingested solids or liquids to leave the stomach.
Colonic filling (%) at 6 hours
时间窗: Day 2 (6 hours)
Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.
Colonic geometric center (GC) at 24 hours
时间窗: Day 2 ( 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
- Colonic transit summarized by GC at 48 hours hours hours colonic transit summarized by GC at 4 and 48 hours Colonic transit at 4 and 48 hours(Day 2 (48 hours))
- Ascending Colon Emptying (ACE) T1/2(Day 2)
研究者
Michael Camilleri
MD, Consultant, Professor of Medicine
Mayo Clinic