A Study to Evaluate 90-Day Safety of Tapentadol(CG5503) Immediate Release (IR) or Oxycodone Immediate Release in Patients With Chronic Pain
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|ClinicalTrials.gov Identifier: NCT00364546|
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : June 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Pain Intensity Assessment Arthralgia Sciatica Low Back Pain||Drug: CG 5503;tapentadol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||877 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Double-Blind, Active-Control, Parallel-Group, 90-Day Safety Study of CG5503 Immediate Release (IR) or Oxycodone IR in Subjects With Chronic Pain From Low Back Pain or Osteoarthritis of the Hip or Knee|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||July 2007|
- The primary outcomes include incidence of adverse events, changes in laboratory measures, results of physical exams, and results of 12-Lead ECG.
- The secondary outcomes, among others, include COWS and SOWS assessments; patient assessment of constipation symptoms; vomiting and sleep assessments; pain intensity assessment; patient global impression of change.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00364546
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|