Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hallux Valgus

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Requires primary unilateral first metatarsal bunionectomy surgery alone or with ipsilateral hammertoe repair under regional anesthesia. The patient requires collateral orthopedic surgical procedures other than ipsilateral hammertoe repair may not be enrolled into the study. 18 years of age or older Moderate to severe pain within eight (8) hours following completion of the required bunionectomy surgery Exclusion Criteria: Allergy to shellfish Signs of nasal congestion, nasal polyps, mucosal lesions of the nostrils, postnasal drip of any etiology or any clinically significant nasal pathology that may affect the absorption of study medication or the assessment of safety. Chronic respiratory insufficiency such that treatment with an opioid analgesic is contraindicated Additional Inclusion/Exclusion Criteria May Apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Intranasal morphine 3.75 mg | Drug: Intranasal Morphine (MNS075) 3.75 mg<br>* Intranasal Morphine (MNS075) 3.75 mg<br>|
| Experimental: 2<br>Intranasal morphine 7.5 mg | Drug: Intranasal morphine (MNS075) 7.5 mg<br>* Intranasal morphine (MNS075) 7.5 mg<br>|
| Experimental: 3<br>Intranasal morphine 15 mg | Drug: Intranasal morphine (MNS075) 15 mg<br>* Intranasal morphine (MNS075) 15 mg<br>|
| Experimental: 4<br>Intranasal morphine 30 mg | Drug: Intranasal morphine (MNS075) 30 mg<br>* Intranasal morphine (MNS075) 30 mg<br>|
| Active Comparator: 5<br>Intravenous morphine 7.5 mg | Drug: Intravenous Morphine 7.5 mg<br>* Intravenous Morphine 7.5 mg<br>|
| Placebo Comparator: 6<br>Intranasal placebo | Drug: Intranasal placebo<br>* Intranasal placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS Total Pain Relief 0-4 hours (TOTPAR4) |  | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other measures of pain relief |  | Several time points | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post surgical pain, Bunionectomy, Hammer Toe Syndrome, Morphine