Status:
COMPLETED
Efficacy and Safety of Intranasal Morphine for Pain After Elective Orthopedic Surgery
Lead Sponsor:
Javelin Pharmaceuticals
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Multiple-center, multiple-dose, randomized, double-blind, six-arm, active- and placebo-controlled study in patients with moderate to severe post-surgical pain from elective orthopedic surgery with saf...
Detailed Description
Multiple-center, multiple-dose, randomized, double-blind, six-arm, active- and placebo-controlled study of repeated intermittent PRN dosing for 24 hours of Intranasal (IN) Morphine Nasal Spray (MNS075...
Eligibility Criteria
Inclusion
- Over 18 years old
- Scheduled (within two weeks of the screening visit) to undergo elective orthopedic surgery (e.g., bunionectomy, arthroscopic knee surgery, rotator cuff repair)
- Moderate to severe pain within 8 hours following completion of the required surgery
Exclusion
- Previous anaphylactic or serious allergic reaction to shellfish or opioids
- History of sleep apnea
- Other Inclusion/Exclusion Criteria May Apply
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT00390039
Start Date
May 1 2006
End Date
September 1 2006
Last Update
January 14 2008
Active Locations (7)
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1
Arizona Research Center
Phoenix, Arizona, United States, 85023
2
HOPE Research Institute
Phoenix, Arizona, United States, 85050
3
Vertex Clinical Research
Bakersfield, California, United States, 93311
4
University Orthopedics Center
State College, Pennsylvania, United States, 16801