Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-29 @ 4:39 AM
Study NCT ID:
NCT00707057
Status:
COMPLETED
Last Update Posted:
2011-03-24
First Post:
2008-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ibuprofen Extended-Release Dental Pain Study
Sponsor:
SCOLR Pharma, Inc.
Organization:
Study Overview
Official Title:
Ibuprofen 600 mg Extended-Release (ER) Multiple-Dose Dental Pain Study
Status:
COMPLETED
Status Verified Date:
2011-03
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:
The purpose of this study is to evaluate the efficacy and safety of multiple doses of Ibuprofen 600 mg Extended-Release Tablets in a study of dental pain following extraction of third molar teeth.
Detailed Description:
This is a single-center, multiple-dose, randomized, placebo-controlled, double-blinded, parallel group trial to evaluate the efficacy and safety of multiple doses of Ibuprofen 600 mg Extended-Release Tablets in a study of dental pain following extraction of third molar teeth. The surgery will consist of surgical extraction of 1-2 impacted third molars, of which one must be a mandibular impaction that is partially impacted in either tissue or bone. Subjects will be stratified according to baseline pain intensity, as rated on an 11-point pain intensity numerical rating scale (PI-NRS)and gender.
Study Oversight
Has Oversight DMC:
False
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?: