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Efficacy of Oxycodone/Naloxone(OXN), Versus Oxycodone (OXY), for the Reduction of Intensity of Opioid-induced Constipation in Pain Patients

NCT01014559 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2015-09-28

No results posted yet for this study

Summary

The primary objective of this trial is to study the efficacy of oxycodone/naloxone prolonged release tablets (OXN PR), compared to oxycodone prolonged release tablets (Oxy PR), for the reduction of the intensity of opioid-induced constipation symptoms in patients treated for cancer or non-cancer pain.

Conditions

Interventions

DRUG

Oxycodone Naloxone

Oxycodone Naloxone PR Tablet taken twice daily

DRUG

Oxycodone PR Tablets

Oxycodone PR Tablets taken twice daily

Sponsors & Collaborators

  • Mundipharma SAS

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-06-30
Completion
2013-02-28

Countries

  • France

Study Locations

More Related Trials

Entities

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 NCT01014559 on ClinicalTrials.gov