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

Dental Pain Clinical Trial

Official title:

A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group Analgesic Efficacy Trial of Oral ARRY-371797 in Subjects Undergoing Third Molar Extraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663767
• Other study ID #: ARRAY-797-222
• Secondary ID: C4411009
• Status: Completed
• Phase: Phase 2
• Start date: April 7, 2008
• Est. completion date: June 20, 2008

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 20, 2008
• Est. primary completion date: June 20, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pain
• Toothache

Intervention

Drug:
• Placebo; oral
dose 1, dose 2
• Placebo; oral
dose 1
• ARRY-371797, p38 inhibitor; oral
dose 1: multiple dose levels
• ARRY-371797, p38 inhibitor; oral
dose 1: multiple dose levels; dose 2
• Celecoxib, COX-2 inhibitor; oral
dose 1
• Placebo; oral
dose 2
• ARRY-371797, p38 inhibitor; oral
dose 2

Locations

Country	Name	City	State
United States	PPD Phase I Clinic	Austin	Texas
United States	Lifetree Clinical Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

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