MedTrace Logo

Effects of 500 mg Immediate Release and Extended Release Methylnaltrexone on Loperamide-induced Delay of the Oro-cecal and Whole-gut Transit Time in Healthy Subjects

NCT01596777 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-10-26

No results posted yet for this study

Summary

The purpose of this study is to describe the effects of methylnaltrexone in preventing loperamide-induced delay of the oro-cecal and whole-gut transit time and measure pharmacokinetics of methylnaltrexone after subcutaneous and oral administration of immediate release and extended release capsules.

Conditions

  • Intestinal Obstruction

Interventions

DRUG

Loperamide

20 ml Loperamid-ratiopharm® Lösung (ratiopharm) in 180 ml apple juice prepared before administration

DRUG

Loperamide placebo

200 ml apple juice

DRUG

Methylnaltrexone placebo

Methylnaltrexone placebo capsule (identical to MNTX IR and MNTX ER)

DRUG

Methylnaltrexone 12 mg sc.

RELISTOR 12 mg/0.6 ml Injektionslösung (Wyeth)

DRUG

Methylnaltrexone IR capsule

Methylnaltrexone bromide 500 mg IR capsule

DRUG

Methylnaltrexone ER capsule

Methylnaltrexone bromide 500 mg ER capsule

DEVICE

Colon Transit

3x1 capsules containing radio-opaque marker of 6 different shapes (in two consecutive study periods, capsules with different shapes of the markers are given)

DRUG

Sulfasalazine

500 mg Azulfidine® (Pharmacia)

Sponsors & Collaborators

  • University Medicine Greifswald

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-03-31
Completion
2010-05-31

Countries

  • Germany

Study Locations

More Related Trials

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 NCT01596777 on ClinicalTrials.gov