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Trial record 1 of 1 for:    NCT00663767
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A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction

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ClinicalTrials.gov Identifier: NCT00663767
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 18, 2008
First Posted Date  ICMJE April 22, 2008
Last Update Posted Date February 9, 2021
Actual Study Start Date  ICMJE April 7, 2008
Actual Primary Completion Date June 20, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2011)
  • Assess the efficacy of the study drug dosed postoperatively in terms of total pain relief (TOTPAR). [ Time Frame: 6 hours post-dose ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 21, 2008)
Total pain relief (TOTPAR) through 6 hours following the first dose of study medication (DOSE 1) [ Time Frame: 6 hours post-dose ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2011)
Assess the efficacy of the study drug (versus placebo and celecoxib) in terms of pain relief measurements [including TOTPAR, total pain intensity (TPI) and time to rescue medication]. [ Time Frame: Duration of study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2008)
  • Peak pain relief (PPR) relative to pre-DOSE 1, the highest pain-relief (PR) score achieved at any time point during the post DOSE 1 evaluation period prior to the receipt of DOSE 2 [ Time Frame: Any time point post-dose ]
  • Time to perceptible PR following DOSE 1 [ Time Frame: Post-dose ]
  • Time to meaningful PR following DOSE 1 [ Time Frame: Post-dose ]
  • Time to onset of analgesia following DOSE 1 [ Time Frame: Post-dose ]
  • Time to rescue medication following DOSE 1 [ Time Frame: Post-dose ]
  • Patient's Global Evaluation of Study Medication [ Time Frame: 6 hours post DOSE 1 ]
  • Symptom distress scale questionnaire score [ Time Frame: 24 hours post DOSE 1 ]
  • Incidence and severity of adverse events [ Time Frame: Duration of study ]
  • Incidence and severity of clinical findings on physical examination [ Time Frame: Duration of study ]
  • Incidence and severity of clinical laboratory abnormalities [ Time Frame: Duration of study ]
  • Mean change from baseline in vital signs (blood pressure, temperature, pulse) [ Time Frame: Duration of study ]
  • Mean change from baseline in 12-lead ECG parameters [ Time Frame: Duration of study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction
Official Title  ICMJE A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group Analgesic Efficacy Trial of Oral ARRY-371797 in Subjects Undergoing Third Molar Extraction
Brief Summary This is a Phase 2 study designed to test the ability of investigational study drug ARRY-371797 to reduce pain in a postoperative pain model (third molar extraction), and to further evaluate the drug's safety. Approximately 250 subjects from the US will be enrolled in this study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dental Pain
Intervention  ICMJE
  • Drug: Placebo; oral
    dose 1, dose 2
  • Drug: Placebo; oral
    dose 1
  • Drug: ARRY-371797, p38 inhibitor; oral
    dose 1: multiple dose levels
  • Drug: ARRY-371797, p38 inhibitor; oral
    dose 1: multiple dose levels; dose 2
  • Drug: Celecoxib, COX-2 inhibitor; oral
    dose 1
  • Drug: Placebo; oral
    dose 2
  • Drug: ARRY-371797, p38 inhibitor; oral
    dose 2
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo; oral
  • Experimental: Placebo, ARRY-371797
    Interventions:
    • Drug: Placebo; oral
    • Drug: ARRY-371797, p38 inhibitor; oral
  • Experimental: ARRY-371797, Placebo
    Interventions:
    • Drug: ARRY-371797, p38 inhibitor; oral
    • Drug: Placebo; oral
  • Experimental: ARRY-371797
    Intervention: Drug: ARRY-371797, p38 inhibitor; oral
  • Active Comparator: Celecoxib, Placebo
    Interventions:
    • Drug: Celecoxib, COX-2 inhibitor; oral
    • Drug: Placebo; oral
  • Experimental: Celecoxib, ARRY-371797
    Interventions:
    • Drug: Celecoxib, COX-2 inhibitor; oral
    • Drug: ARRY-371797, p38 inhibitor; oral
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2008)
250
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 20, 2008
Actual Primary Completion Date June 20, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Scheduled for outpatient oral surgical procedure to remove 3 or more 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:

  • Evidence or history of clinically significant dermatologic, hematological, renal, endocrine (e.g. poorly controlled diabetes), pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, ophthalmologic, or allergic disease (including clinically significant drug allergies that could impact the conduct of this study, but excluding untreated, asymptomatic, seasonal allergies at time of study drug dosing).
  • Positive urine drug screen within 28 days prior to first dose of study drug.
  • Use of prohibited prescription drugs, or grapefruit juice within 7 days of first dose of study drug; prohibited medications are defined as nonsteroidal and steroidal antiinflammatory drugs, analgesics including opioids (except low dose aspirin for myocardial infarction prophylaxis), P450 CYP3A substrates or inhibitors (strong or moderate).
  • Additional criteria exist.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00663767
Other Study ID Numbers  ICMJE ARRAY-797-222
C4411009 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP