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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00390039
• Other study ID #: MOR-003
• Status: Completed
• Phase: Phase 3
• First received: October 17, 2006
• Last updated: January 11, 2008
• Start date: May 2006
• Est. completion date: September 2006

Study information

• Verified date: January 2008
• Source: Javelin Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Intranasal Morphine
MNS075 7.5mg q1h PRN
• Placebo
IN Placebo q1h PRN
• IV morphine
IV morphine 7.5mg q3h PRN
• Placebo
IV Placebo q3h PRN
• Intranasal morphine
MNS075 15mg q3h PRN
• Placebo
IN Placebo q3h PRN

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Javelin Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sum of the Pain Intensity Differences (SPID) over 0-24 hours based on Visual Analog Scale (VAS)		Multiple	No
Secondary	Other measures of pain		Multiple	No