|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | SCOLR Pharma, Inc. |
|---|---|
| Collaborators: |
AAIPharma Jean Brown Research |
| Information provided by: | SCOLR Pharma, Inc. |
| ClinicalTrials.gov Identifier: | NCT00707057 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Post-Operative Pain Third Molar Extraction |
Drug: Ibuprofen 600 mg Extended-Release Tablets Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Ibuprofen 600 mg Extended-Release (ER) Multiple-Dose Dental Pain Study |
| Estimated Enrollment: | 240 |
| Study Start Date: | June 2008 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
One-hundred and sixty subjects will be randomly assigned to the Ibuprofen 600 mg ER treatment group based on gender and baseline pain intensity rating.
|
Drug: Ibuprofen 600 mg Extended-Release Tablets
Ibuprofen 600 mg Extended-Release Tablet: One 600 mg tablet given twice daily (BID)at times = 0,12,24, and 36 hours.
|
|
B: Placebo Comparator
Eighty subjects will be randomly assigned to the Placebo treatment group based on gender and baseline pain intensity rating.
|
Drug: Placebo
Placebo: One matching placebo tablet given twice daily (BID) at times = 0, 12, 24, and 36 hours.
|
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 numerical rating and gender.
Eligibility| Ages Eligible for Study: | 16 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Utah | |
| Jean Brown Research | |
| Salt Lake City, Utah, United States, 84124 | |
| Principal Investigator: | Steven E Christensen, D.D.S. | Jean Brown Research |
More Information
| Responsible Party: | SCOLR Pharma, Inc. ( Tanya Raco, Associate VP of Regulatory Affairs ) |
| Study ID Numbers: | SCO-0001 |
| Study First Received: | June 26, 2008 |
| Last Updated: | October 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00707057 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Inflammatory Agents Ibuprofen Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Pain Pharmacologic Actions Signs and Symptoms Pathologic Processes |
Postoperative Complications Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Pain, Postoperative |