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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00542035
First Posted: October 10, 2007
Last Update Posted: January 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Array BioPharma
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542035


Locations
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
ClinicalTrials.gov Identifier: NCT00542035     History of Changes
Other Study ID Numbers: ARRAY-797-221
First Submitted: October 5, 2007
First Posted: October 10, 2007
Last Update Posted: January 11, 2012
Last Verified: January 2012

Keywords provided by Array BioPharma:
Analgesia

Additional relevant MeSH terms:
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms