Status:
COMPLETED
Multiple Dose Dental Pain Study Of Ibuprofen Extended Release
Lead Sponsor:
Pfizer
Conditions:
Pain
Eligibility:
All Genders
16-40 years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 22 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2011
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01266161
Start Date
November 22 2010
End Date
March 31 2011
Last Update
August 15 2018
Active Locations (2)
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1
Central Texas Oral Surgery Associates
Austin, Texas, United States, 78705
2
Premier Research
Austin, Texas, United States, 78705