NCT00390039

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

Randomized, Double-Blind, Active- and Placebo-Controlled Study of Analgesic Efficacy and Safety of Repeated Dosing of MNS075 (Intranasal Morphine), IV Morphine, and Placebo in Acute Post-Operative Pain After Elective Orthopedic Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Javelin Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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) 7.5 mg and 15 mg, 7.5 mg IV morphine infusions and placebo (either IN or IV), 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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Intranasal Morphine	MNS075 7.5mg q1h PRN
DRUG	Placebo	IN Placebo q1h PRN
DRUG	IV morphine	IV morphine 7.5mg q3h PRN
DRUG	Placebo	IV Placebo q3h PRN
DRUG	Intranasal morphine	MNS075 15mg q3h PRN
DRUG	Placebo	IN Placebo q3h PRN

Timeline

• Start date: 2006-05-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2006-10-19
• Last updated: 2008-01-14

Locations

7 sites across 1 country: United States