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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pain, Postoperative

In brief

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.

Key facts

Study ID

NCT00390039

Run by

Javelin Pharmaceuticals

People needed

256

Starts

2006-05-01

Expected to finish

2006-09-01

Last updated by the study team

2008-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Previous anaphylactic or serious allergic reaction to shellfish or opioids
• History of sleep apnea
• Other Inclusion/Exclusion Criteria May Apply

Where it is running

• Arizona Research Center — Phoenix, Arizona, United States
• HOPE Research Institute — Phoenix, Arizona, United States
• Vertex Clinical Research — Bakersfield, California, United States
• University Orthopedics Center — State College, Pennsylvania, United States
• SCIREX Corporation — Austin, Texas, United States
• SCIREX Corporation — San Marcos, Texas, United States
• Jean Brown Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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