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

January 11, 2008 updated by: Javelin Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

256

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center
      • Phoenix, Arizona, United States, 85050
        • Hope Research Institute
    • California
      • Bakersfield, California, United States, 93311
        • Vertex Clinical Research
    • Pennsylvania
      • State College, Pennsylvania, United States, 16801
        • University Orthopedics Center
    • Texas
      • Austin, Texas, United States, 78705
        • SCIREX Corporation
      • San Marcos, Texas, United States, 78666
        • SCIREX Corporation
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Jean Brown Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
MNS075 7.5mg
Drug: Intranasal Morphine
MNS075 7.5mg q1h PRN
Placebo Comparator: B
Placebo
Drug: Placebo
IN Placebo q1h PRN
Drug: Placebo
IV Placebo q3h PRN
Drug: Placebo
IN Placebo q3h 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
IN Placebo q1h PRN
Drug: Placebo
IV Placebo q3h PRN
Drug: Placebo
IN Placebo q3h PRN
Placebo Comparator: F
Placebo
Drug: Placebo
IN Placebo q1h PRN
Drug: Placebo
IV Placebo q3h PRN
Drug: Placebo
IN Placebo q3h PRN

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Other measures of pain
Time Frame: Multiple
Multiple

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Javelin Pharmaceuticals

Investigators

  • Study Director: Javelin Pharmaceuticals, Javelin Pharmacueticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

October 17, 2006

First Submitted That Met QC Criteria

October 17, 2006

First Posted (Estimate)

October 19, 2006

Study Record Updates

Last Update Posted (Estimate)

January 14, 2008

Last Update Submitted That Met QC Criteria

January 11, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOR-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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