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Sponsored by: |
Javelin Pharmaceuticals |
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Information provided by: | Javelin Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00388011 |
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.
Condition | Intervention | Phase |
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Hallux Valgus |
Drug: Intranasal Morphine (MNS075) 3.75 mg Drug: Intravenous Morphine 7.5 mg Drug: Intranasal morphine (MNS075) 7.5 mg Drug: Intranasal morphine (MNS075) 15 mg Drug: Intranasal morphine (MNS075) 30 mg Drug: Intranasal placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 Pain Following Orthopedic Surgery |
Enrollment: | 187 |
Study Start Date: | January 2005 |
Study Completion Date: | August 2005 |
Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Intranasal morphine 3.75 mg
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Drug: Intranasal Morphine (MNS075) 3.75 mg
Intranasal Morphine (MNS075) 3.75 mg
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2: Experimental
Intranasal morphine 7.5 mg
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Drug: Intranasal morphine (MNS075) 7.5 mg
Intranasal morphine (MNS075) 7.5 mg
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3: Experimental
Intranasal morphine 15 mg
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Drug: Intranasal morphine (MNS075) 15 mg
Intranasal morphine (MNS075) 15 mg
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4: Experimental
Intranasal morphine 30 mg
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Drug: Intranasal morphine (MNS075) 30 mg
Intranasal morphine (MNS075) 30 mg
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5: Active Comparator
Intravenous morphine 7.5 mg
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Drug: Intravenous Morphine 7.5 mg
Intravenous Morphine 7.5 mg
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6: Placebo Comparator
Intranasal placebo
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Drug: Intranasal placebo
Intranasal placebo
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Additional Inclusion/Exclusion Criteria May Apply
Responsible Party: | Javelin Pharmaceuticals ( Amy Cohen/Director, Clinical Operations ) |
Study ID Numbers: | MOR-002 |
Study First Received: | October 12, 2006 |
Last Updated: | January 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00388011 |
Health Authority: | United States: Food and Drug Administration |
Post surgical pain Bunionectomy Hammer Toe Syndrome Morphine |
Hallux Valgus Morphine Musculoskeletal Diseases |
Pain Congenital Abnormalities Foot Deformities |
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |