Multiple Dose Dental Pain Study Of Ibuprofen Extended Release

Completed · Phase 3 · Has a placebo group

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT01266161

Run by

Pfizer

People needed

106

Starts

2010-11-22

Expected to finish

2011-03-31

Last updated by the study team

2018-08-15

Who can join

Age: 16 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Central Texas Oral Surgery Associates — Austin, Texas, United States
• Premier Research — Austin, Texas, United States

Full record on ClinicalTrials.gov

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