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A Randomised Placebo Controlled Study of OXN PR for Severe Parkinson's Disease Associated Pain

NCT01439100 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2014-02-06

No results posted yet for this study

Summary

To demonstrate superiority of OXN PR compared to placebo with respect to analgesic efficacy in subjects with chronic severe pain associated with Parkinson's disease (PD), as assessed by averaged 24 hour pain scores collected for 7 days prior to the clinic visits

Conditions

  • Parkinson's Disease With Severe Pain

Interventions

DRUG

Oxycodone/Naloxone Prolonged Release tablets

DRUG

Placebo

Dummy tablet

Sponsors & Collaborators

  • Mundipharma Research GmbH & Co KG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-08-31
Completion
2013-10-31

Countries

  • Czechia
  • Germany
  • Hungary
  • Poland
  • Romania
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT01439100 on ClinicalTrials.gov