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A Randomised, Double Blind, Placebo and Active Controlled, Double Dummy,Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Subjects With Moderate to Severe, Chronic Nonmalignant Pain

NCT01971632 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 463

Last updated 2018-10-23

No results posted yet for this study

Summary

The primary objective was to demonstrate the superiority of OXN over placebo over time from the initial dose of study medication to multiple pain events (inadequate analgesia) during the double blind phase.

Conditions

  • Subjects With Moderate to Severe, Chronic Nonmalignant Pain

Interventions

DRUG

Oxycodone & naloxone combination, prolonged release

DRUG

placebo oxycodone / naloxone

Sponsors & Collaborators

  • Mundipharma Research GmbH & Co KG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2006-05-31
Completion
2006-05-31

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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 NCT01971632 on ClinicalTrials.gov