Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390039
Status:
COMPLETED
Last Update Posted:
2008-01-14
First Post:
2006-10-17
Brief Title:
Efficacy and Safety of Intranasal Morphine for Pain After Elective Orthopedic Surgery
Sponsor:
Javelin Pharmaceuticals
Organization:
Javelin Pharmaceuticals
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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 75 mg and 15 mg 75 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None