Multiple Dose Dental Pain Study Of Ibuprofen Extended Release

• Status: Completed
• Trial end date: 2011-03-31
• Target enrollment: 0
• Participant gender: All

Summary

The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide analgesic efficacy superior to placebo over 12-hour dosing intervals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Ibuprofen

Criteria

Inclusion Criteria:

• Males and females 16 to 40 years of age

• Subjects who undergo surgical removal of at least two third molars

• One of which must be a partial or full bony mandibular impaction

• Subjects must have at least moderate baseline pain (a score of 2 on the categorical pain severity rating scale) confirmed by a score of at least 50 mm on the 100-mm visual analog scale-pain severity rating scale (VAS-PSR)

Exclusion Criteria:

• Acute localized dental infection at the time of surgery that could confound the post-surgical evaluation

• Presence or history of any significant organ disease

• Use of prescription or OTC first generation antihistamines

• Females who are pregnant, lactating or of childbearing potential and not using a medically approved method to prevent pregnancy