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Effect of Methylnaltrexone on GI Transit in Healthy Volunteers

NCT01055704 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2012-06-25

Study results available
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Summary

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:

1. Methylnaltrexone administered subcutaneously enhances gastrointestinal motility with acceleration of overall colonic transit, and ascending colon emptying of solids in healthy humans.
2. Methylnaltrexone significantly accelerates colonic transit that is delayed by codeine

Conditions

  • Gastric Motility Disorder

Interventions

DRUG

Methylnaltrexone only

0.30 mg/kg subcutaneous injection daily

DRUG

Codeine only

30 mg taken orally four times daily for 5 days

DRUG

Methylnaltrexone + codeine

Methylnaltrexone 0.30 mg/kg by subcutaneous injection once daily and codeine 30 mg taken orally four times daily for 5 days

DRUG

Placebo + placebo

Placebo subcutaneous injection once daily and placebo taken orally four times daily for 5 days

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Michael Camilleri, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-02-28
Completion
2010-02-28

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 NCT01055704 on ClinicalTrials.gov