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

Dental Pain Clinical Trial

Official title:

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-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: NCT00542035
• Other study ID #: ARRAY-797-221
• Secondary ID: C4411008
• Status: Completed
• Phase: Phase 2
• Start date: November 11, 2007
• Est. completion date: February 11, 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: February 11, 2008
• Est. primary completion date: February 11, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Dental Pain
• Toothache

Intervention

Drug:
• ARRY-371797, p38 inhibitor; oral
dose 1, dose 2
• Placebo; oral
dose 1, dose 2
• Placebo; oral
dose 1
• ARRY-371797, p38 inhibitor; oral
dose 2

Locations

Country	Name	City	State
United States	SCIREX Research Center	Salt Lake City	Utah
United States	SCIREX Research Center	San Marcos	Texas

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 either perioperatively or postoperatively in terms of total pain relief (TOTPAR) and total pain intensity (visual analog scale, VAS).		6 hours post dose 2
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	Compare the efficacy of the study drug dosed perioperatively versus postoperatively in terms of total pain intensity (VAS).		Duration of study