drugset / Trial / NCT00388011

Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery

NCT00388011

Phase 2 Completed 187 enrolled Javelin Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2005-01
Primary completion
2005-08
Completion
2005-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Morphine Other / unclassified 3.75 mg Intranasal
Subject Morphine Other / unclassified 7.5 mg Intranasal
Subject Morphine Other / unclassified 15 mg Intranasal
Subject Morphine Other / unclassified 30 mg Intranasal

Indications

No indication recorded.