A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain
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|ClinicalTrials.gov Identifier: NCT00361504|
Recruitment Status : Completed
First Posted : August 8, 2006
Results First Posted : September 4, 2009
Last Update Posted : April 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Hip Osteoarthritis, Knee Lower Back Pain Pain||Drug: Oxycodone CR Drug: Tapentadol (CG5503) ER||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1123 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A One-Year, Randomized, Open-Label, Parallel-Arm, Phase 3 Long-Term Safety Trial, With Controlled Adjustment of Dose, of Multiple Doses of CG5503 PR and Oxycodone CR in Subjects With Chronic Pain|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
Experimental: Tapentadol (CG5503)
Tapentadol (CG5503) extended release (ER) 100 to 250 mg twice daily (BID) for up to one year.
Drug: Tapentadol (CG5503) ER
Tapentadol (CG5503) ER 50 mg oral tablet BID administered for first 3 days, 100 mg oral tablet BID administered for next 4 days, 100 to 250 mg oral tablet BID administered for the next 51 weeks.
Other Name: CG5503
Active Comparator: Oxycodone
Oxycodone controlled release (CR) 20 to 50 mg twice daily (BID) for up to one year.
Drug: Oxycodone CR
Oxycodone CR 10 mg oral tablet BID administered for first 3 days, 20 mg oral tablet BID administered for next 4 days, 20 to 50 mg oral tablet BID administered for the next 51 weeks.
- Number of Participants With Treatment-emergent Adverse Events (TEAE) [ Time Frame: 52 weeks ]The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.
- Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS) [ Time Frame: Baseline, Week 52 ]The Participants indicated the average level of pain experienced, at each study visit, over the previous 24 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Baseline was the average pain intensity scores measured prior to randomization (At Week 1). At Week 52 again the average pain intensity scores were collected and the change in scores at Week 52 from the baseline scores was considered as the change from baseline in average pain intensity scores at Week 52.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00361504
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|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|