Efficacy and Safety of Intranasal Morphine for Pain After Elective Orthopedic Surgery

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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 safety observed for a total of 30 hours post first dose.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Javelin Pharmaceuticals
• Treatments: Morphine

Criteria

Inclusion Criteria:

• 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 Criteria:

• Previous anaphylactic or serious allergic reaction to shellfish or opioids

• History of sleep apnea

Other Inclusion/Exclusion Criteria May Apply