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

This study has been completed.
Information provided by:
Javelin Pharmaceuticals Identifier:
First received: October 17, 2006
Last updated: January 11, 2008
Last verified: January 2008
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.

Condition Intervention Phase
Pain, Postoperative
Drug: Intranasal Morphine
Drug: Placebo
Drug: IV morphine
Drug: Intranasal morphine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Javelin Pharmaceuticals:

Primary Outcome Measures:
  • Sum of the Pain Intensity Differences (SPID) over 0-24 hours based on Visual Analog Scale (VAS) [ Time Frame: Multiple ]

Secondary Outcome Measures:
  • Other measures of pain [ Time Frame: Multiple ]

Enrollment: 256
Study Start Date: May 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
MNS075 7.5mg
Drug: Intranasal Morphine
MNS075 7.5mg q1h PRN
Placebo Comparator: B
Drug: Placebo
IN Placebo q1h PRN
Active Comparator: C
IV Morphine
Drug: IV morphine
IV morphine 7.5mg q3h PRN
Experimental: E
MNS075 15mg
Drug: Intranasal morphine
MNS075 15mg q3h PRN
Placebo Comparator: D
Drug: Placebo
IV Placebo q3h PRN
Placebo Comparator: F
Drug: Placebo
IN Placebo q3h PRN

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00390039

United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85023
HOPE Research Institute
Phoenix, Arizona, United States, 85050
United States, California
Vertex Clinical Research
Bakersfield, California, United States, 93311
United States, Pennsylvania
University Orthopedics Center
State College, Pennsylvania, United States, 16801
United States, Texas
SCIREX Corporation
Austin, Texas, United States, 78705
SCIREX Corporation
San Marcos, Texas, United States, 78666
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Javelin Pharmaceuticals
Study Director: Javelin Pharmaceuticals Javelin Pharmacueticals
  More Information

Responsible Party: Javelin Pharmaceuticals Identifier: NCT00390039     History of Changes
Other Study ID Numbers: MOR-003
Study First Received: October 17, 2006
Last Updated: January 11, 2008

Keywords provided by Javelin Pharmaceuticals:
Pain, postoperative
Surgery, orthopedic

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on May 25, 2017