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

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.

Study Overview

• Status: Completed
• Conditions: Dental Pain
• Intervention / Treatment: Drug: ARRY-371797, p38 inhibitor; oral; Drug: Placebo; oral; Drug: Placebo; oral; Drug: Placebo; oral; Drug: ARRY-371797, p38 inhibitor; oral; Drug: ARRY-371797, p38 inhibitor; oral; Drug: Celecoxib, COX-2 inhibitor; oral

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Phase I Clinic
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Lifetree Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; oral; dose 1, dose 2; Drug: Placebo; oral; dose 1; Drug: Placebo; oral; dose 2
Experimental: ARRY-371797	Drug: ARRY-371797, p38 inhibitor; oral; dose 2; Drug: ARRY-371797, p38 inhibitor; oral; dose 1: multiple dose levels; Drug: ARRY-371797, p38 inhibitor; oral; dose 1: multiple dose levels; dose 2
Experimental: Placebo, ARRY-371797	Drug: ARRY-371797, p38 inhibitor; oral; dose 2; Drug: Placebo; oral; dose 1, dose 2; Drug: Placebo; oral; dose 1; Drug: Placebo; oral; dose 2; Drug: ARRY-371797, p38 inhibitor; oral; dose 1: multiple dose levels; Drug: ARRY-371797, p38 inhibitor; oral; dose 1: multiple dose levels; dose 2
Experimental: ARRY-371797, Placebo	Drug: ARRY-371797, p38 inhibitor; oral; dose 2; Drug: Placebo; oral; dose 1, dose 2; Drug: Placebo; oral; dose 1; Drug: Placebo; oral; dose 2; Drug: ARRY-371797, p38 inhibitor; oral; dose 1: multiple dose levels; Drug: ARRY-371797, p38 inhibitor; oral; dose 1: multiple dose levels; dose 2
Active Comparator: Celecoxib, Placebo	Drug: Placebo; oral; dose 1, dose 2; Drug: Placebo; oral; dose 1; Drug: Placebo; oral; dose 2; Drug: Celecoxib, COX-2 inhibitor; oral; dose 1
Experimental: Celecoxib, ARRY-371797	Drug: ARRY-371797, p38 inhibitor; oral; dose 2; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs.	Duration of study
Assess the efficacy of the study drug dosed postoperatively in terms of total pain relief (TOTPAR).	6 hours post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2008
• Primary Completion (Actual): June 20, 2008
• Study Completion (Actual): June 20, 2008

Study Registration Dates

• First Submitted: April 18, 2008
• First Submitted That Met QC Criteria: April 21, 2008
• First Posted (Estimate): April 22, 2008

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 7, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Facial Pain; Toothache; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Celecoxib; Cyclooxygenase 2 Inhibitors
• Other Study ID Numbers: ARRAY-797-222; C4411009 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.