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

NCT00663767 | Completed Phase 2

• 2 other identifiers: ARRAY-797-222C4411009
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

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.

Conditions

Dental Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Drug: Placebo; oral

Placebo, ARRY-371797

EXPERIMENTAL

Drug: Placebo; oral; Drug: ARRY-371797, p38 inhibitor; oral

ARRY-371797, Placebo

EXPERIMENTAL

Drug: ARRY-371797, p38 inhibitor; oral; Drug: Placebo; oral

ARRY-371797

EXPERIMENTAL

Drug: ARRY-371797, p38 inhibitor; oral

Celecoxib, Placebo

ACTIVE COMPARATOR

Drug: Celecoxib, COX-2 inhibitor; oral; Drug: Placebo; oral

Celecoxib, ARRY-371797

EXPERIMENTAL

Drug: Celecoxib, COX-2 inhibitor; oral; Drug: ARRY-371797, p38 inhibitor; oral

Interventions

Placebo; oral DRUG

dose 1, dose 2

Placebo

ARRY-371797, p38 inhibitor; oral DRUG

dose 1: multiple dose levels

ARRY-371797, Placebo

Celecoxib, COX-2 inhibitor; oral DRUG

dose 1

Celecoxib, ARRY-371797; Celecoxib, Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

PPD Phase I Clinic

Austin, Texas, 78744, United States

Location

Lifetree Clinical Research

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Conditions

Toothache

Interventions

ARRY-371797; Celecoxib; Cyclooxygenase 2 Inhibitors

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 22, 2008
• Study Start: April 7, 2008
• Primary Completion: June 20, 2008
• Study Completion: June 20, 2008
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

US (2)