Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery

This study has been completed.

Sponsor:

Information provided by:

Javelin Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00388011

First received: October 12, 2006

Last updated: January 11, 2008

Last verified: January 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

October 12, 2006

Last Updated Date

January 11, 2008

Start Date ^ICMJE

January 2005

Primary Completion Date

August 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

VAS Total Pain Relief 0-4 hours (TOTPAR4) [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

VAS Total Pain Relief 0-4 hours (TOTPAR4)

Change History

Complete list of historical versions of study NCT00388011 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Other measures of pain relief [ Time Frame: Several time points ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Other measures of pain relief

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery

Official Title ^ICMJE

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

Brief Summary

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.

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Hallux Valgus

Intervention ^ICMJE

Drug: Intranasal Morphine (MNS075) 3.75 mg
Intranasal Morphine (MNS075) 3.75 mg
Drug: Intravenous Morphine 7.5 mg
Intravenous Morphine 7.5 mg
Drug: Intranasal morphine (MNS075) 7.5 mg
Intranasal morphine (MNS075) 7.5 mg
Drug: Intranasal morphine (MNS075) 15 mg
Intranasal morphine (MNS075) 15 mg
Drug: Intranasal morphine (MNS075) 30 mg
Intranasal morphine (MNS075) 30 mg
Drug: Intranasal placebo
Intranasal placebo

Study Arm (s)

Experimental: 1
Intranasal morphine 3.75 mg

Intervention: Drug: Intranasal Morphine (MNS075) 3.75 mg
Experimental: 2
Intranasal morphine 7.5 mg

Intervention: Drug: Intranasal morphine (MNS075) 7.5 mg
Experimental: 3
Intranasal morphine 15 mg

Intervention: Drug: Intranasal morphine (MNS075) 15 mg
Experimental: 4
Intranasal morphine 30 mg

Intervention: Drug: Intranasal morphine (MNS075) 30 mg
Active Comparator: 5
Intravenous morphine 7.5 mg

Intervention: Drug: Intravenous Morphine 7.5 mg
Placebo Comparator: 6
Intranasal placebo

Intervention: Drug: Intranasal placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

187

Completion Date

August 2005

Primary Completion Date

August 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00388011

Other Study ID Numbers ^ICMJE

MOR-002

Has Data Monitoring Committee

Responsible Party

Amy Cohen/Director, Clinical Operations, Javelin Pharmaceuticals

Study Sponsor ^ICMJE

Javelin Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Douglas G Stoker, DPM

Jean Brown Research

Information Provided By

Javelin Pharmaceuticals

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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