Efficacy and Safety of Intranasal Morphine for Pain After Elective Orthopedic Surgery
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Intranasal Morphine
Placebo
IV morphine
Placebo
Intranasal morphine
Placebo
Sponsored by

About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Pain, postoperative, Surgery, orthopedic, Morphine
Eligibility 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
Sites / Locations
- Arizona Research Center
- HOPE Research Institute
- Vertex Clinical Research
- University Orthopedics Center
- SCIREX Corporation
- SCIREX Corporation
- Jean Brown Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Placebo Comparator
Active Comparator
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
A
B
C
E
D
F
Arm Description
MNS075 7.5mg
Placebo
IV Morphine
MNS075 15mg
Placebo
Placebo
Outcomes
Primary Outcome Measures
Sum of the Pain Intensity Differences (SPID) over 0-24 hours based on Visual Analog Scale (VAS)
Secondary Outcome Measures
Other measures of pain
Full Information
NCT ID
NCT00390039
First Posted
October 17, 2006
Last Updated
January 11, 2008
Sponsor
Javelin Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00390039
Brief Title
Efficacy and Safety of Intranasal Morphine for Pain After Elective Orthopedic Surgery
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 Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Javelin Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Pain, postoperative, Surgery, orthopedic, Morphine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
256 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
MNS075 7.5mg
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
C
Arm Type
Active Comparator
Arm Description
IV Morphine
Arm Title
E
Arm Type
Experimental
Arm Description
MNS075 15mg
Arm Title
D
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
F
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Intranasal Morphine
Intervention Description
MNS075 7.5mg q1h PRN
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IN Placebo q1h PRN
Intervention Type
Drug
Intervention Name(s)
IV morphine
Intervention Description
IV morphine 7.5mg q3h PRN
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IV Placebo q3h PRN
Intervention Type
Drug
Intervention Name(s)
Intranasal morphine
Intervention Description
MNS075 15mg q3h PRN
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IN Placebo q3h PRN
Primary Outcome Measure Information:
Title
Sum of the Pain Intensity Differences (SPID) over 0-24 hours based on Visual Analog Scale (VAS)
Time Frame
Multiple
Secondary Outcome Measure Information:
Title
Other measures of pain
Time Frame
Multiple
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javelin Pharmaceuticals
Organizational Affiliation
Javelin Pharmacueticals
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
HOPE Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Vertex Clinical Research
City
Bakersfield
State/Province
California
ZIP/Postal Code
93311
Country
United States
Facility Name
University Orthopedics Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
SCIREX Corporation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
SCIREX Corporation
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Intranasal Morphine for Pain After Elective Orthopedic Surgery
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