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

This study has been completed.
Information provided by (Responsible Party):
Array BioPharma Identifier:
First received: October 5, 2007
Last updated: January 6, 2012
Last verified: January 2012
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care

Further study details as provided by Array BioPharma:

Primary Outcome Measures:
  • 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). [ Time Frame: 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. [ Time Frame: Duration of study ]

Secondary Outcome Measures:
  • Compare the efficacy of the study drug dosed perioperatively versus postoperatively in terms of total pain intensity (VAS). [ Time Frame: Duration of study ]

Enrollment: 103
Study Start Date: October 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARRY-371797 Drug: ARRY-371797, p38 inhibitor; oral
dose 1, dose 2
Experimental: Placebo, ARRY-371797 Drug: Placebo; oral
dose 1
Drug: ARRY-371797, p38 inhibitor; oral
dose 2
Placebo Comparator: Placebo Drug: Placebo; oral
dose 1, dose 2


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00542035

United States, Texas
SCIREX Research Center
San Marcos, Texas, United States, 78666
United States, Utah
SCIREX Research Center
Salt Lake City, Utah, United States, 84117
Sponsors and Collaborators
Array BioPharma
  More Information

Responsible Party: Array BioPharma Identifier: NCT00542035     History of Changes
Other Study ID Numbers: ARRAY-797-221
Study First Received: October 5, 2007
Last Updated: January 6, 2012

Keywords provided by Array BioPharma:

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on September 21, 2017