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

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-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

NCT00542035

Enrollment

103

Registered

2007-10-10

Start date

2007-11-11

Completion date

2008-02-11

Last updated

2021-02-21

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

Conditions

Dental Pain

Keywords

Analgesia

Brief summary

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.

Interventions

DRUGARRY-371797, p38 inhibitor; oral

dose 1, dose 2

DRUGPlacebo; oral

dose 1, dose 2

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
Assess the efficacy of the study drug dosed either perioperatively or postoperatively in terms of total pain relief (TOTPAR) and total pain intensity (visual analog scale, VAS).	6 hours post dose 2
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
Compare the efficacy of the study drug dosed perioperatively versus postoperatively in terms of total pain intensity (VAS).	Duration of study

Countries

United States

Outcome results

None listed

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