Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390312
Status:
COMPLETED
Last Update Posted:
2008-01-04
First Post:
2006-10-17
Brief Title:
Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction
Sponsor:
Javelin Pharmaceuticals
Organization:
Javelin Pharmaceuticals
Study Overview
Official Title:
Randomized Double-Blind Placebo Controlled Dose Ranging Single Dose Comparison of Analgesic Efficacy and Safety of Intranasal Morphine Immediate Release Oral Morphine Intravenous Morphine and Placebo in Postsurgical Dental Pain
Status:
COMPLETED
Status Verified Date:
2007-12
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:
This study involves approximately 200 patients designed to evaluate the efficacy and safety of intranasal IN morphine 75 mg and 15 mg intravenous morphine IV 75 mg immediate release oral PO morphine 60 mg or placebo in patients with acute postsurgical pain following third molar extraction
Detailed Description:
Diagnosis and Main Criteria for Inclusion Dental outpatients undergoing the removal of 3 or more third molars 2 of which were required to be mandibular and both must be bony impacted third molars
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