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

Phase 3

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: IV morphine; Drug: Intranasal morphine; Drug: Placebo

• Registration Number: NCT00390039
• Lead Sponsor: Javelin Pharmaceuticals

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 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.

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Study First Submitted: 2006-10-17
• Study First Submitted QC: 2006-10-17
• Study First Posted: 2006-10-19
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-11
• Last Update Posted: 2008-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	IV morphine	IV Morphine
A	Intranasal morphine	MNS075 7.5mg
D	Placebo	Placebo
B	Placebo	Placebo
E	Intranasal morphine	MNS075 15mg
F	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Sum of the Pain Intensity Differences (SPID) over 0-24 hours based on Visual Analog Scale (VAS)	Multiple

Secondary Outcome Measures

Name	Time	Method
Other measures of pain	Multiple

Trial Locations

Locations (6)

HOPE Research Institute; 🇺🇸 Phoenix, Arizona, United States

SCIREX Corporation; 🇺🇸 San Marcos, Texas, United States

University Orthopedics Center; 🇺🇸 State College, Pennsylvania, United States

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

Vertex Clinical Research; 🇺🇸 Bakersfield, California, United States

Jean Brown Research; 🇺🇸 Salt Lake City, Utah, United States