Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery

January 11, 2008 updated by: Javelin Pharmaceuticals

Randomized, Double-Blind, Placebo and Comparator-Controlled, Dose-Response Trial of the Efficacy and Safety of Intranasal Morphine, Intravenous Morphine and Placebo in Patients With Moderate to Severe Pain Following Orthopedic Surgery

Study designed to evaluate the efficacy and safety of Intranasal (IN) Morphine Nasal Spray (MNS075) 3.75 mg, 7.5 mg, 15 mg, and 30 mg, intravenous (IV) morphine 7.5 mg, or IN placebo in patients with moderate to severe post-surgical pain following orthopedic surgery. After initial dosing, up to six (6) doses of IN MNS075 7.5 mg or 15 mg for up to twenty-four (24) hours will be evaluated. The rescue dose remained the same for each.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diagnosis and Main Criteria for Inclusion:

Healthy adult patients (18 to 76 years old), who scored PS-1 to PS-3 according to the American Society of Anesthesiologists Physical Status Classification System, requiring primary, unilateral, first metatarsal bunionectomy surgery alone or with ipsilateral hammertoe repair without additional collateral procedures.

Study Type

Interventional

Enrollment (Actual)

187

Phase

  • Phase 2

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:

  • Requires primary unilateral first metatarsal bunionectomy surgery alone or with ipsilateral hammertoe repair under regional anesthesia. The patient requires collateral orthopedic surgical procedures other than ipsilateral hammertoe repair may not be enrolled into the study.
  • 18 years of age or older
  • Moderate to severe pain within eight (8) hours following completion of the required bunionectomy surgery

Exclusion Criteria:

  • Allergy to shellfish
  • Signs of nasal congestion, nasal polyps, mucosal lesions of the nostrils, postnasal drip of any etiology or any clinically significant nasal pathology that may affect the absorption of study medication or the assessment of safety.
  • Chronic respiratory insufficiency such that treatment with an opioid analgesic is contraindicated

Additional 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: 1
Intranasal morphine 3.75 mg
Drug: Intranasal Morphine (MNS075) 3.75 mg
Intranasal Morphine (MNS075) 3.75 mg
Experimental: 2
Intranasal morphine 7.5 mg
Drug: Intranasal morphine (MNS075) 7.5 mg
Intranasal morphine (MNS075) 7.5 mg
Experimental: 3
Intranasal morphine 15 mg
Drug: Intranasal morphine (MNS075) 15 mg
Intranasal morphine (MNS075) 15 mg
Experimental: 4
Intranasal morphine 30 mg
Drug: Intranasal morphine (MNS075) 30 mg
Intranasal morphine (MNS075) 30 mg
Active Comparator: 5
Intravenous morphine 7.5 mg
Drug: Intravenous Morphine 7.5 mg
Intravenous Morphine 7.5 mg
Placebo Comparator: 6
Intranasal placebo
Drug: Intranasal placebo
Intranasal placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
VAS Total Pain Relief 0-4 hours (TOTPAR4)
Time Frame: 4 hours
4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Other measures of pain relief
Time Frame: Several time points
Several time points

Collaborators and Investigators

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

Sponsor

Javelin Pharmaceuticals

Investigators

  • Principal Investigator: Douglas G Stoker, DPM, Jean Brown Research

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

January 1, 2005

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

October 12, 2006

First Submitted That Met QC Criteria

October 12, 2006

First Posted (Estimate)

October 13, 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-002

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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