NCT00663767

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2008-04-07
• Primary completion: 2008-06-20
• Completion: 2008-06-20
• First posted: 2008-04-22
• Last updated: 2021-02-09

Locations

2 sites across 1 country: United States