Status:
COMPLETED
OXN PR Compared to OxyPR to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in OA Subjects
Lead Sponsor:
Mundipharma Research GmbH & Co KG
Conditions:
Chronic Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 demonstr...
Detailed Description
Subjects with moderate to severe pain due to osteoarthritis (OA) will be randomised to oxycodone/naloxone prolonged release (OXN PR) or oxycodone prolonged release tablets (OxyPR) alone to demonstrate...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Moderate to severe chronic nonmalignant OA and that require around-the-clock opioid therapy.
- Exclusion criteria:
- Females who are pregnant or lactating.
- Subjects with evidence of significant structural abnormalities of the gastrointestinal tract.
- Subjects with evidence of impaired liver/kidney function upon entry into the study
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT00902837
Start Date
May 1 2009
End Date
July 1 2010
Last Update
October 22 2018
Active Locations (36)
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1
Ghent, Belgium
2
Dr R Flasar
Brno, Czechia, 60200
3
FN U Svate Anny
Brno, Czechia, 65691
4
Urazova nemocnice v Brne
Brno, Czechia, 66250