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

NCT00542035 | Completed Phase 2

• 2 other identifiers: ARRAY-797-221C4411008
• Study Type: interventional
• Target: 103
• 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 either perioperatively or postoperatively in a third molar extraction pain model, and to further evaluate the drug's safety. Approximately 150 subjects from the US will be enrolled in this study.

Conditions

Dental Pain

Keywords

Analgesia

Outcome Measures

Primary Outcomes (2)

• Assess the efficacy of the study drug dosed either perioperatively or postoperatively in terms of total pain relief (TOTPAR) and total pain intensity (visual analog scale, VAS).

  6 hours post dose 2

• 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)

• Compare the efficacy of the study drug dosed perioperatively versus postoperatively in terms of total pain intensity (VAS).

  Duration of study

Study Arms (3)

ARRY-371797

EXPERIMENTAL

Drug: ARRY-371797, p38 inhibitor; oral

Placebo, ARRY-371797

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Drug: Placebo; oral

Interventions

ARRY-371797, p38 inhibitor; oral DRUG

dose 1, dose 2

ARRY-371797

Placebo; oral DRUG

dose 1, dose 2

Placebo

Eligibility Criteria

• Age: 18 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 2 ipsilateral 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:

• Positive urine drug screen.
• Use of prescription or nonprescription drugs, herbal or dietary supplements, vitamins, or grapefruit juice within 14 days prior to first dose of study drug.
• Additional criteria exist.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

SCIREX Research Center

San Marcos, Texas, 78666, United States

Location

SCIREX Research Center

Salt Lake City, Utah, 84117, United States

Location

MeSH Terms

Conditions

Toothache; Agnosia

Interventions

ARRY-371797

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 10, 2007
• Study Start: November 11, 2007
• Primary Completion: February 11, 2008
• Study Completion: February 11, 2008
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

US (2)