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

Phase 2

Completed

• Conditions: Dental Pain
• Interventions: Drug: ARRY-371797, p38 inhibitor; oral; Drug: Celecoxib, COX-2 inhibitor; oral; Drug: Placebo; oral

• Registration Number: NCT00663767
• 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-07
• Study First Submitted: 2008-04-18
• Study First Submitted QC: 2008-04-21
• Study First Posted: 2008-04-22
• Primary Completion: 2008-06-20
• Study Completion: 2008-06-20
• 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: 2021-02-07
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARRY-371797	ARRY-371797, p38 inhibitor; oral	-
Celecoxib, Placebo	Celecoxib, COX-2 inhibitor; oral	-
Celecoxib, Placebo	Placebo; oral	-
Celecoxib, ARRY-371797	Celecoxib, COX-2 inhibitor; oral	-
Celecoxib, ARRY-371797	ARRY-371797, p38 inhibitor; oral	-
Placebo, ARRY-371797	ARRY-371797, p38 inhibitor; oral	-
ARRY-371797, Placebo	ARRY-371797, p38 inhibitor; oral	-
Placebo	Placebo; oral	-
Placebo, ARRY-371797	Placebo; oral	-
ARRY-371797, Placebo	Placebo; oral	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

PPD Phase I Clinic; 🇺🇸 Austin, Texas, United States

Lifetree Clinical Research; 🇺🇸 Salt Lake City, Utah, United States