A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-11

Study Completion Date

2008-02-11

Brief Summary

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This is a Phase 2 study designed to test the ability of investigational study drug ARRY-371797 to reduce pain either perioperatively or postoperatively in a third molar extraction pain model, and to further evaluate the drug's safety. Approximately 150 subjects from the US will be enrolled in this study.

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Detailed Description

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Conditions

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Dental Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ARRY-371797

Group Type EXPERIMENTAL

ARRY-371797, p38 inhibitor; oral

Intervention Type DRUG

dose 1, dose 2

Placebo, ARRY-371797

Group Type EXPERIMENTAL

Placebo; oral

Intervention Type DRUG

dose 1

ARRY-371797, p38 inhibitor; oral

Intervention Type DRUG

dose 2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo; oral

Intervention Type DRUG

dose 1, dose 2

Interventions

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ARRY-371797, p38 inhibitor; oral

dose 1, dose 2

Intervention Type DRUG

Placebo; oral

dose 1, dose 2

Intervention Type DRUG

Placebo; oral

dose 1

Intervention Type DRUG

ARRY-371797, p38 inhibitor; oral

dose 2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Scheduled for outpatient oral surgical procedure to remove 2 ipsilateral third molars, at least 1 of which is mandibular and fully or partially impacted by bone.
* Females of childbearing potential must be willing to use an acceptable method of contraception within 14 days prior to first dose of study drug until the completion of the follow-up procedures.
* Body weight \>50 kg (110 lbs).
* Good health determined by medical history, physical examination, vital signs and clinical laboratory results of non-clinical significance.
* Additional criteria exist.

Exclusion Criteria

* Positive urine drug screen.
* Use of prescription or nonprescription drugs, herbal or dietary supplements, vitamins, or grapefruit juice within 14 days prior to first dose of study drug.
* Additional criteria exist.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No