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Sponsors and Collaborators: |
Ortho-McNeil Janssen Scientific Affairs, LLC Grünenthal GmbH |
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Information provided by: | Ortho-McNeil Janssen Scientific Affairs, LLC |
ClinicalTrials.gov Identifier: | NCT00814580 |
The purpose of this study is to evaluate how tapentadol Immediate Release (IR) compares with oxycodone Immediate Release (IR) for treating moderate to severe post-operative pain after elective arthroscopic shoulder surgery.
Condition | Intervention | Phase |
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Postoperative Pain |
Drug: Oxycodone IR Drug: Tapentadol IR |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Multi-Center, Parallel-Group Study of Tapentadol Immediate Release (IR) vs. Oxycodone IR for the Treatment of Subjects With Acute Post-Operative Pain Following Elective Arthroscopic Shoulder Surgery |
Estimated Enrollment: | 370 |
Estimated Study Completion Date: | October 2009 |
Arms | Assigned Interventions |
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001: Experimental |
Drug: Tapentadol IR
50 or 100 mg 4-6 hours PRN; maximum 600 mg a day for 7 days but can be up 9 days
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002: Active Comparator |
Drug: Oxycodone IR
5 or 10 mg 4-6 hours PRN; maximum 60 mg a day for 7 days but can be up to 9 days
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email | info1@veritasmedicine.com |
Study Director: | Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial | Ortho-McNeil Janssen Scientific Affairs, LLC |
Responsible Party: | Ortho-McNeil Janssen Scientific Affairs, LLC ( Vice President, Medical Affairs ) |
Study ID Numbers: | CR015040, Grunenthal protocol KF5503/49, R331333PAI3022 |
Study First Received: | December 23, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00814580 |
Health Authority: | United States: Food and Drug Administration |
Bankart procedure labral tear repair rotator cuff repair analgesia oxycodone |
arthroscopic shoulder surgery tapentadol opioid postoperative pain |
Lacerations Signs and Symptoms Postoperative Complications |
Oxycodone Pain Pain, Postoperative |
Pathologic Processes Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Analgesics, Opioid Pharmacologic Actions |