Efficacy and Safety of Intranasal Morphine for Pain After Elective Orthopedic Surgery - Full Text View

Sponsor:	Javelin Pharmaceuticals
Information provided by:	Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00390039

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Surgery

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
A: Experimental MNS075 7.5mg	Drug: Intranasal Morphine MNS075 7.5mg q1h PRN
B: Placebo Comparator Placebo	Drug: Placebo IN Placebo q1h PRN
C: Active Comparator IV Morphine	Drug: IV morphine IV morphine 7.5mg q3h PRN
E: Experimental MNS075 15mg	Drug: Intranasal morphine MNS075 15mg q3h PRN
D: Placebo Comparator Placebo	Drug: Placebo IV Placebo q3h PRN
F: Placebo Comparator 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 ( Javelin Pharmaceuticals )
Study ID Numbers:	MOR-003
Study First Received:	October 17, 2006
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00390039 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Javelin Pharmaceuticals:

Pain, postoperative
Surgery, orthopedic
Morphine

Additional relevant MeSH terms:

Morphine
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pain
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes

Postoperative Complications
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Pain, Postoperative
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010