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The Effect of Naldemedine on Opioid-induced Bowel Dysfunction

NCT06334198 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-03-28

No results posted yet for this study

Summary

Opioid-induced bowel dysfunction is a frequent condition during opioid therapy for chronic pain. Indeed, up to 90% of people on opioid treated patients experience constipation. Standard laxative treatment is often ineffective in opioid-induced constipation, but peripheral acting mu-receptor antagonists (PAMORAs) have the potential to block the effects of opioids in the gastrointestinal tract while preserving the central analgesic effect. In this study, we will investigated the effects of Naldemedine in preventing the development of opioid-induced bowel dysfunction and constipation during treatment with tramadol

Conditions

Interventions

DRUG

Naldemedine

Naldemedine is administered orally once daily in the morning in a dosage of 0.2 mg.

DRUG

Placebo

Placebo is administered orally once daily in the morning.

DRUG

Tramadol

In both arms, tramadol is administered orally twice daily in a dosage of 100 mg (daily total of 200mg).

Sponsors & Collaborators

  • Asbjørn Mohr Drewes

    lead OTHER

Principal Investigators

  • Asbjørn Mohr Drewes · Aalborg University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-03-12
Primary Completion
2025-03-31
Completion
2025-03-31

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 NCT06334198 on ClinicalTrials.gov