Multiple Dose Dental Pain Study Of Ibuprofen Extended Release

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Ibuprofen 600 mg ER; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01266161

B3491001

AK-10-13 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 16 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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106 participants in 2 patient groups, including a placebo group

Ibuprofen 600 mg extended release

Experimental group

Treatment:

Drug: Ibuprofen 600 mg ER

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo