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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT00542035
First received: October 5, 2007
Last updated: January 6, 2012
Last verified: January 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT00542035     History of Changes
Other Study ID Numbers: ARRAY-797-221
Study First Received: October 5, 2007
Last Updated: January 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Array BioPharma:
Analgesia

Additional relevant MeSH terms:
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014