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

NCT00663767 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2021-02-09

No results posted yet for this study

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.

Conditions

  • Dental Pain

Interventions

DRUG

Placebo; oral

dose 1, dose 2

DRUG

Placebo; oral

dose 1

DRUG

ARRY-371797, p38 inhibitor; oral

dose 1: multiple dose levels

DRUG

ARRY-371797, p38 inhibitor; oral

dose 1: multiple dose levels; dose 2

DRUG

Celecoxib, COX-2 inhibitor; oral

dose 1

DRUG

Placebo; oral

dose 2

DRUG

ARRY-371797, p38 inhibitor; oral

dose 2

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-07
Primary Completion
2008-06-20
Completion
2008-06-20

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00663767 on ClinicalTrials.gov