Efficacy and Safety of Intranasal Morphine for Pain After Elective Orthopedic Surgery
Information source: Javelin Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative
Intervention: Intranasal Morphine (Drug); Placebo (Drug); IV morphine (Drug); Placebo (Drug); Intranasal morphine (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Javelin Pharmaceuticals Official(s) and/or principal investigator(s):
Javelin Pharmaceuticals, Study Director, Affiliation: Javelin Pharmacueticals
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Sum of the Pain Intensity Differences (SPID) over 0-24 hours based on Visual Analog Scale (VAS)
Secondary outcome: Other measures of pain
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
HOPE Research Institute, Phoenix, Arizona 85050, United States
Arizona Research Center, Phoenix, Arizona 85023, United States
Vertex Clinical Research, Bakersfield, California 93311, United States
University Orthopedics Center, State College, Pennsylvania 16801, United States
SCIREX Corporation, Austin, Texas 78705, United States
SCIREX Corporation, San Marcos, Texas 78666, United States
Jean Brown Research, Salt Lake City, Utah 84124, United States
Additional Information
Starting date: May 2006
Ending date: September 2006
Last updated: January 11, 2008
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