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The Influence of Tramadol on Opioid-induced Bowel Dysfunction

NCT06385561 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-04-26

No results posted yet for this study

Summary

Tramadol is a weak opioid and widely used to treat moderate to severe pain. Stronger opioids are known to inhibit gastrointestinal motility and secretion, however the effects of tramadol on gastrointestinal function remains less understood. The aim of this study was to determine to what degree tramadol causes opioid-induced bowel dysfunction by using an objective design to explore gastrointestinal transit, motility pattern, secretion, and colonic volume, in a group of healthy male volunteers.

Conditions

Interventions

DRUG

Tramadol

Tramadol is administered orally twice daily in a dosage of 100 mg (daily total of 200 mg)

DRUG

Placebo

Placebo is administered orally twice daily.

Sponsors & Collaborators

  • Asbjørn Mohr Drewes

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-11
Primary Completion
2023-05-15
Completion
2023-05-15

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT06385561 on ClinicalTrials.gov