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

Phase 2

Completed

• Conditions: Dental Pain
• Interventions: Drug: Placebo; oral; Drug: ARRY-371797, p38 inhibitor; oral

• Registration Number: NCT00542035
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-05
• Study First Posted: 2007-10-10
• Study Start: 2007-11-11
• Primary Completion: 2008-02-11
• Study Completion: 2008-02-11
• Disposition First Submitted: 2009-12-09
• Disposition First Submitted QC: 2009-12-09
• Disposition First Posted: 2009-12-11
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo, ARRY-371797	ARRY-371797, p38 inhibitor; oral	-
Placebo, ARRY-371797	Placebo; oral	-
ARRY-371797	ARRY-371797, p38 inhibitor; oral	-
Placebo	Placebo; oral	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Compare the efficacy of the study drug dosed perioperatively versus postoperatively in terms of total pain intensity (VAS).	Duration of study

Trial Locations

Locations (1)

SCIREX Research Center; 🇺🇸 Salt Lake City, Utah, United States