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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
187
Intranasal Morphine (MNS075) 3.75 mg
Intravenous Morphine 7.5 mg
Intranasal morphine (MNS075) 7.5 mg
VAS Total Pain Relief 0-4 hours (TOTPAR4)
Time frame: 4 hours
Other measures of pain relief
Time frame: Several time points
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Intranasal morphine (MNS075) 15 mg
Intranasal morphine (MNS075) 30 mg
Intranasal placebo