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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Dental Pain

Treatments: Drug: ARRY-371797, p38 inhibitor; oral; Drug: Placebo; oral

Study type: Interventional

Funder types: Industry

Identifiers

NCT00542035

ARRAY-797-221

C4411008 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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103 participants in 3 patient groups, including a placebo group

ARRY-371797

Experimental group

Treatment:

Drug: ARRY-371797, p38 inhibitor; oral

Drug: ARRY-371797, p38 inhibitor; oral

Placebo, ARRY-371797

Experimental group

Treatment:

Drug: Placebo; oral

Drug: ARRY-371797, p38 inhibitor; oral

Drug: ARRY-371797, p38 inhibitor; oral

Drug: Placebo; oral

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo; oral

Drug: Placebo; oral