NCT02737059

Effect of Naloxegol on Gastric, Small Bowel, and Colonic Transit in Healthy Subjects

A Phase I Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of Naloxegol on Gastric, Small Bowel, and Colonic Transit in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Michael Camilleri · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Constipation Drug Induced

Interventions

Type	Name	Description
DRUG	Naloxegol	25mg daily
DRUG	Codeine	30mg 4 times daily
DRUG	codeine placebo	4 times daily (placebo will be made to match the codeine)
DRUG	naloxegol placebo	placebo will match naloxegol, given daily

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-05-10
• Completion: 2017-05-10
• First posted: 2016-04-13
• Last updated: 2017-08-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study