Multiple Dose Dental Pain Study Of Ibuprofen Extended Release

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-22

Study Completion Date

2011-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ibuprofen 600 mg extended release

Group Type EXPERIMENTAL

Ibuprofen 600 mg ER

Intervention Type DRUG

One 600 mg caplet dosed at 0, 12, 24 and 36 hours

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

One placebo caplet dosed at times 0, 12, 24 and 36 hours

Interventions

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Ibuprofen 600 mg ER

One 600 mg caplet dosed at 0, 12, 24 and 36 hours

Intervention Type DRUG

Placebo

One placebo caplet dosed at times 0, 12, 24 and 36 hours

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No