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Safety and Efficacy of Tapentadol Immediate Release (IR) and Oxycodone Immediate Release (IR) for Treatment of Acute Post-op Pain Following Elective Arthroscopic Shoulder Surgery
This study is not yet open for participant recruitment.
Verified by Ortho-McNeil Janssen Scientific Affairs, LLC, January 2009
Sponsors and Collaborators: Ortho-McNeil Janssen Scientific Affairs, LLC
Grünenthal GmbH
Information provided by: Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT00814580
  Purpose

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
Postoperative Pain
Drug: Oxycodone IR
Drug: Tapentadol IR
Phase III

Drug Information available for: Oxycodone Oxycodone hydrochloride Tapentadol
U.S. FDA Resources
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

Further study details as provided by Ortho-McNeil Janssen Scientific Affairs, LLC:

Primary Outcome Measures:
  • The primary efficacy measure is the sum of pain intensity difference (SPID) over 3 days. [ Time Frame: Sum of pain intensity difference (SPID) over 3 days will be the primary efficacy measure. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to achieve adequate analgesia; response defined as 50% improvement from baseline in pain intensity; change in pain relief and pain intensity; patient and clinician impression of change; sleep questions; treatment satisfaction [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 370
Estimated Study Completion Date: October 2009
Arms Assigned Interventions
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
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy on the basis of medical history and vital signs and meeting the American Society of Anesthesiology (ASA) physical status I, II, or III
  • Completed screening procedures and have undergone one of the following elective outpatient arthroscopic surgical procedures: rotator cuff repair, labral tear repair, or Bankart repair
  • Received regional anesthesia administered by interscalene nerve block
  • Receive study medication as the first oral analgesic medication following the orthopedic surgical procedure
  • Expected to have moderate to severe pain requiring oral opiods for at least 3 days after surgery

Exclusion Criteria:

  • Patients whose post-operative pain would require non-opioid analgesia as standard of care
  • Received an inadequate block for the surgical procedure
  • Presence of a painful condition that could interfere with subject's assessments or ability to differentiate post-operative shoulder pain from other painful conditions or a condition associated with more severe pain in a location other than the surgical site
  • Took any of the following in the month before randomization: long-acting or controlled-release opiods, immediate-release Class II opioids (e.g.,Opana IR, Percocet, Percodan, oxycodone IR, Dilaudid), intra-articular or systemic steroids except inhalers and topical steroids, or use of NSAIDS within 24 hours of randomization including intraoperative or post-operative NSAIDS (e.g., toradol)
  • Treated with anticonvulsants, monoamine oxidase inhibitors, tricyclic antidepressants, neuroleptics, serotonin norepinephrine reuptake inhibitors within 2 weeks before randomization
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814580

Contacts
Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email info1@veritasmedicine.com

Sponsors and Collaborators
Ortho-McNeil Janssen Scientific Affairs, LLC
Grünenthal GmbH
Investigators
Study Director: Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial Ortho-McNeil Janssen Scientific Affairs, LLC
  More Information

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

Keywords provided by Ortho-McNeil Janssen Scientific Affairs, LLC:
Bankart procedure
labral tear repair
rotator cuff repair
analgesia
oxycodone
arthroscopic shoulder surgery
tapentadol
opioid
postoperative pain

Study placed in the following topic categories:
Lacerations
Signs and Symptoms
Postoperative Complications
Oxycodone
Pain
Pain, Postoperative

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 15, 2009