Back to results

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

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Pain, postoperative, Surgery, orthopedic, Morphine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Label

Arm Description

MNS075 7.5mg

Placebo

IV Morphine

MNS075 15mg

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

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

Arm Type

Experimental

Arm Description

MNS075 7.5mg

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Arm Type

Active Comparator

Arm Description

IV Morphine

Arm Title

Arm Type

Experimental

Arm Description

MNS075 15mg

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

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

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

We'll reach out to this number within 24 hrs