Efficacy and Safety of Intranasal Morphine for Pain After Elective Orthopedic Surgery

Study Overview
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Brief Summary
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Multiple-center, multiple-dose, randomized, double-blind, six-arm, active- and placebo-controlled study in patients with moderate to severe post-surgical pain from elective orthopedic surgery with safety observed for a total of 30 hours post first dose.

Detailed Description
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Multiple-center, multiple-dose, randomized, double-blind, six-arm, active- and placebo-controlled study of repeated intermittent PRN dosing for 24 hours of Intranasal (IN) Morphine Nasal Spray (MNS075) 7.5 mg and 15 mg, 7.5 mg IV morphine infusions and placebo (either IN or IV), in patients with moderate to severe post-surgical pain from elective orthopedic surgery with safety observed for a total of 30 hours post first dose.

Official Title
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Randomized, Double-Blind, Active- and Placebo-Controlled Study of Analgesic Efficacy and Safety of Repeated Dosing of MNS075 (Intranasal Morphine), IV Morphine, and Placebo in Acute Post-Operative Pain After Elective Orthopedic Surgery

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Intranasal Morphine
* Drug: Placebo
* Drug: IV morphine
* Drug: Placebo
* Drug: Intranasal morphine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years old Scheduled (within two weeks of the screening visit) to undergo elective orthopedic surgery (e.g., bunionectomy, arthroscopic knee surgery, rotator cuff repair) Moderate to severe pain within 8 hours following completion of the required surgery Exclusion Criteria: Previous anaphylactic or serious allergic reaction to shellfish or opioids History of sleep apnea Other 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: A<br>MNS075 7.5mg | Drug: Intranasal Morphine<br>* MNS075 7.5mg q1h PRN<br>|
| Placebo Comparator: B<br>Placebo | Drug: Placebo<br>* IN Placebo q1h PRN<br>|
| Active Comparator: C<br>IV Morphine | Drug: IV morphine<br>* IV morphine 7.5mg q3h PRN<br>|
| Experimental: E<br>MNS075 15mg | Drug: Intranasal morphine<br>* MNS075 15mg q3h PRN<br>|
| Placebo Comparator: D<br>Placebo | Drug: Placebo<br>* IV Placebo q3h PRN<br>|
| Placebo Comparator: F<br>Placebo | Drug: Placebo<br>* IN Placebo q3h PRN<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sum of the Pain Intensity Differences (SPID) over 0-24 hours based on Visual Analog Scale (VAS) |  | Multiple | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other measures of pain |  | Multiple | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, postoperative, Surgery, orthopedic, Morphine