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

NCT02737059 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2017-08-30

No results posted yet for this study

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.

Conditions

  • Constipation Drug Induced

Interventions

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Michael Camilleri

    lead OTHER

Principal Investigators

  • Michael Camilleri, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2017-05-10
Completion
2017-05-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02737059 on ClinicalTrials.gov