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OXN PR Compared to OxyPR to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in OA Subjects

NCT00902837 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2018-10-22

No results posted yet for this study

Summary

The primary objectives are

* to demonstrate that the treatment with OXN PR tablets is non-inferior to the treatment with OxyPR with regards to analgesic efficacy and locomotor function.
* to demonstrate that subjects with moderate to severe OA pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone

Conditions

  • Chronic Osteoarthritis

Interventions

DRUG

Oxycodone naloxone prolonged release tablets (OXN)

DRUG

oxycodone prolonged release tablet

DRUG

oxycodone naloxone tablet

Sponsors & Collaborators

  • Mundipharma Research GmbH & Co KG

    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
2009-05-31
Primary Completion
2010-04-30
Completion
2010-07-31

Countries

  • Belgium
  • Czechia
  • Finland
  • Germany
  • Hungary
  • Spain

Study Locations

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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 NCT00902837 on ClinicalTrials.gov