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

This study has been completed.
Sponsor:
Information provided by:
Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00390039
First received: October 17, 2006
Last updated: January 11, 2008
Last verified: January 2008
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other measures of pain [ Time Frame: Multiple ] [ Designated as safety issue: No ]

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
Placebo
 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
Placebo
 Drug: Placebo
IV Placebo q3h PRN
Placebo Comparator: F
Placebo
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390039

Locations
United States, Arizona
HOPE Research Institute
Phoenix, Arizona, United States, 85050
Arizona Research Center
Phoenix, Arizona, United States, 85023
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
Investigators
Study Director: Javelin Pharmaceuticals Javelin Pharmacueticals
  More Information

No publications provided

Responsible Party: Javelin Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00390039     History of Changes
Other Study ID Numbers: MOR-003
Study First Received: October 17, 2006
Last Updated: January 11, 2008
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Morphine
Analgesics, Opioid
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on May 22, 2013