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Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery

NCT00388011 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2008-01-14

No results posted yet for this study

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.

Conditions

  • Hallux Valgus

Interventions

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

Sponsors & Collaborators

  • Javelin Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Douglas G Stoker, DPM · Jean Brown Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2005-08-31
Completion
2005-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00388011 on ClinicalTrials.gov