NCT00388011

Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: Javelin Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hallux Valgus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-01-01
• Primary completion: 2005-08-01
• Completion: 2005-08-01
• First posted: 2006-10-13
• Last updated: 2008-01-14