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

A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group Analgesic Efficacy Trial of Oral ARRY-371797 in Subjects Undergoing Third Molar Extraction

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00663767

Enrollment

250

Registered

2008-04-22

Start date

2008-04-07

Completion date

2008-06-20

Last updated

2021-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Pain

Brief summary

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.

Interventions

DRUGPlacebo; oral

dose 1, dose 2

DRUGARRY-371797, p38 inhibitor; oral

dose 1: multiple dose levels

DRUGCelecoxib, COX-2 inhibitor; oral

dose 1

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
Assess the efficacy of the study drug dosed postoperatively in terms of total pain relief (TOTPAR).	6 hours post-dose
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs.	Duration of study

Secondary

Measure	Time frame
Assess the efficacy of the study drug (versus placebo and celecoxib) in terms of pain relief measurements [including TOTPAR, total pain intensity (TPI) and time to rescue medication].	Duration of study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026