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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | MNS075 7.5mg |
|
| B | Placebo Comparator | Placebo |
|
| C | Active Comparator | IV Morphine |
|
| E | Experimental | MNS075 15mg |
|
| D | Placebo Comparator | Placebo |
|
| F | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal Morphine | Drug | MNS075 7.5mg q1h PRN |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of the Pain Intensity Differences (SPID) over 0-24 hours based on Visual Analog Scale (VAS) | Multiple |
| Measure | Description | Time Frame |
|---|---|---|
| Other measures of pain | Multiple |
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Inclusion Criteria:
Exclusion Criteria:
Other Inclusion/Exclusion Criteria May Apply
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| Name | Affiliation | Role |
|---|---|---|
| Javelin Pharmaceuticals | Javelin Pharmacueticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85023 | United States | ||
| HOPE Research Institute |
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| Drug |
IN Placebo q1h PRN |
|
| IV morphine | Drug | IV morphine 7.5mg q3h PRN |
|
| Placebo | Drug | IV Placebo q3h PRN |
|
| Intranasal morphine | Drug | MNS075 15mg q3h PRN |
|
| Placebo | Drug | IN Placebo q3h PRN |
|
| Phoenix |
| Arizona |
| 85050 |
| United States |
| Vertex Clinical Research | Bakersfield | California | 93311 | United States |
| University Orthopedics Center | State College | Pennsylvania | 16801 | United States |
| SCIREX Corporation | Austin | Texas | 78705 | United States |
| SCIREX Corporation | San Marcos | Texas | 78666 | United States |
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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