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

Purpose

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.

Condition	Intervention	Phase
Dental Pain	Drug: Placebo; oral Drug: ARRY-371797, p38 inhibitor; oral Drug: Celecoxib, COX-2 inhibitor; oral	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by Array BioPharma:

Primary Outcome Measures:

Assess the efficacy of the study drug dosed postoperatively in terms of total pain relief (TOTPAR). [ Time Frame: 6 hours post-dose ] [ Designated as safety issue: No ]
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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]. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Enrollment:	250
Study Start Date:	April 2008
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Drug: Placebo; oral dose 1, dose 2
Experimental: Placebo, ARRY-371797	Drug: Placebo; oral dose 1 Drug: ARRY-371797, p38 inhibitor; oral dose 2
Experimental: ARRY-371797, Placebo	Drug: ARRY-371797, p38 inhibitor; oral dose 1: multiple dose levels Drug: Placebo; oral dose 2
Experimental: ARRY-371797	Drug: ARRY-371797, p38 inhibitor; oral dose 1: multiple dose levels; dose 2
Active Comparator: Celecoxib, Placebo	Drug: Celecoxib, COX-2 inhibitor; oral dose 1 Drug: Placebo; oral dose 2
Experimental: Celecoxib, ARRY-371797	Drug: Celecoxib, COX-2 inhibitor; oral dose 1 Drug: ARRY-371797, p38 inhibitor; oral dose 2

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663767

Locations

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

Sponsors and Collaborators

Array BioPharma

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Array BioPharma
ClinicalTrials.gov Identifier:	NCT00663767 History of Changes
Other Study ID Numbers:	ARRAY-797-222
Study First Received:	April 18, 2008
Last Updated:	November 29, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Signs and Symptoms
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
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
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 21, 2013