Status:
COMPLETED
Safety and Efficacy of Tapentadol Immediate Release (IR) and Oxycodone IR for Treatment of Acute Post-op Pain Following Elective Arthroscopic (Surgery Using a Thin Flexible Scope) Shoulder Surgery
Lead Sponsor:
Ortho-McNeil Janssen Scientific Affairs, LLC
Collaborating Sponsors:
Grünenthal GmbH
Conditions:
Postoperative Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate how tapentadol immediate release (IR) and oxycodone IR treat moderate to severe post-operative pain after elective arthroscopic shoulder surgery.
Detailed Description
This is a double-blind (neither the patient nor the study doctor knows the name of the assigned study drug during the study), randomized (study drug selected by chance like flipping a coin), active-co...
Eligibility Criteria
Inclusion
- 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, Bankart repair
- an arthroscopic mini-open rotator cuff repair
- (an arthroscopic distal clavicle resection performed in conjunction with a rotator cuff, labral tear or Bankart repair is also permitted)
- received anesthesia administered to the shoulder by interscalene nerve block
- receive study medication as the first oral analgesic medication following the orthopedic surgical procedure and expected to have moderate to severe pain requiring oral opioids for at least 3 days after surgery.
Exclusion
- Patients whose post-operative pain would require non opioid analgesia as standard of care
- received a non-allowed procedure
- received intraoperative or post-operative anesthesia and/or analgesic medications which are expected to provide post-operative analgesia for \>24 hours after discharge from the PACU (recovery room)
- received intraoperatively \>200 mg fentanyl or the morphine equivalent of another opioid (for the total procedure) or potent inhaled anesthesia (e.g., sevoflurane, isoflurane)
- received IV PCA analgesia (intravenous pump the patient controls) in the PACU or a PACU stay \>8 hours
- expected to require inpatient treatment in a hospital or rehabilitation unit post operatively
- anticipate any surgical procedure(s) within 7 days after the initial shoulder surgery
- have significant nausea and/or vomiting at the time of randomization (patients may receive an anti-emetic prior to or during surgery)
- received any of the following: long-acting or controlled-release opioids within 1-month prior to randomization
- immediate release CII opioid formulations (e.g., Opana IR, Percocet, Percodan, oxycodone IR, Dilaudid) for \>5 days total within 1 month before, and within 24 hours of, randomization
- intra-articular (within a joint) or systemic steroids (except inhalers and topical steroids), within 1 month before randomization (exception, patients on a stable dose of chronic steroids for a minimum of 3 months, for a condition other than the shoulder pain)
- use of non-steroidal anti-inflammatory drugs (NSAIDs) within 24-hours of randomization
- have taken any CIII opioid formulation (e.g., Tylenol with Codeine) \>3 days/week in the 1-month prior to randomization
- treated with anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin norepinephrine reuptake inhibitors (SNRIs) within 2 weeks before randomization
- positive urine drug screen (cocaine, methadone, amphetamines, cannabinoids, opiates, benzodiazepines, barbiturates, and oxycodone)
- have an active systemic or local infection
- significant co-existing autoimmune inflammatory conditions
- history of seizure disorder or epilepsy
- presence of any of the following: mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening
- severe traumatic brain injury, episode(s) of unconsciousness of more than 24 hours duration, or post-traumatic amnesia of more than 24 hours duration within 15 years of screening
- known history of alcohol or drug abuse in the study doctor's judgment based on medical history
- known or suspected to be opioid tolerant or dependent
- known history of laboratory values reflecting severe kidney disease, known history of moderately or severely impaired liver function
- history of allergy to, or hypersensitivity to tapentadol, oxycodone, or other components of the medication
- history (within the past 6 months) of a major psychiatric disorder
- history of suicidal ideation or suicidal attempts within the past 2 years
- currently involved in litigation regarding their shoulder injury, have a disability claim or patients who are receiving Worker's Compensation due to their shoulder injury or are being evaluated to receive disability or Worker's Compensation
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
382 Patients enrolled
Trial Details
Trial ID
NCT00814580
Start Date
December 1 2008
End Date
March 1 2010
Last Update
November 20 2012
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