Clinical Trial: Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

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 Summary:

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.

Sponsor: Javelin Pharmaceuticals

Current Primary Outcome: VAS Total Pain Relief 0-4 hours (TOTPAR4) [ Time Frame: 4 hours ]

Original Primary Outcome: VAS Total Pain Relief 0-4 hours (TOTPAR4)

Current Secondary Outcome: Other measures of pain relief [ Time Frame: Several time points ]

Original Secondary Outcome: Other measures of pain relief

Information By: Javelin Pharmaceuticals

Dates:
Date Received: October 12, 2006
Date Started: January 2005
Date Completion:
Last Updated: January 11, 2008
Last Verified: January 2008