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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Dental Pain

Treatments: Drug: Celecoxib, COX-2 inhibitor; oral; Drug: ARRY-371797, p38 inhibitor; oral; Drug: Placebo; oral

Study type: Interventional

Funder types: Industry

Identifiers

NCT00663767

C4411009 (Other Identifier)

ARRAY-797-222

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 in a postoperative pain model (third molar extraction), and to further evaluate the drug's safety. Approximately 250 subjects from the US will be enrolled in this study.

Enrollment: 250 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Scheduled for outpatient oral surgical procedure to remove 3 or more 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:

• Evidence or history of clinically significant dermatologic, hematological, renal, endocrine (e.g. poorly controlled diabetes), pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, ophthalmologic, or allergic disease (including clinically significant drug allergies that could impact the conduct of this study, but excluding untreated, asymptomatic, seasonal allergies at time of study drug dosing).
• Positive urine drug screen within 28 days prior to first dose of study drug.
• Use of prohibited prescription drugs, or grapefruit juice within 7 days of first dose of study drug; prohibited medications are defined as nonsteroidal and steroidal antiinflammatory drugs, analgesics including opioids (except low dose aspirin for myocardial infarction prophylaxis), P450 CYP3A substrates or inhibitors (strong or moderate).
• Additional criteria exist.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo; oral

Drug: Placebo; oral

Drug: Placebo; oral

Placebo, ARRY-371797

Experimental group

Treatment:

Drug: ARRY-371797, p38 inhibitor; oral

Drug: ARRY-371797, p38 inhibitor; oral

Drug: Placebo; oral

Drug: Placebo; oral

Drug: Placebo; oral

Drug: ARRY-371797, p38 inhibitor; oral

ARRY-371797, Placebo

Experimental group

Treatment:

Drug: ARRY-371797, p38 inhibitor; oral

Drug: ARRY-371797, p38 inhibitor; oral

Drug: Placebo; oral

Drug: Placebo; oral

Drug: Placebo; oral

Drug: ARRY-371797, p38 inhibitor; oral

ARRY-371797

Experimental group

Treatment:

Drug: ARRY-371797, p38 inhibitor; oral

Drug: ARRY-371797, p38 inhibitor; oral

Drug: ARRY-371797, p38 inhibitor; oral

Celecoxib, Placebo

Active Comparator group

Treatment:

Drug: Placebo; oral

Drug: Placebo; oral

Drug: Placebo; oral

Drug: Celecoxib, COX-2 inhibitor; oral

Celecoxib, ARRY-371797

Experimental group

Treatment:

Drug: ARRY-371797, p38 inhibitor; oral

Drug: ARRY-371797, p38 inhibitor; oral

Drug: Celecoxib, COX-2 inhibitor; oral

Drug: ARRY-371797, p38 inhibitor; oral