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

NCT00542035

Last updated date
Study Location
SCIREX Research Center
San Marcos, Texas, 78666, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Dental Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Dental PainA Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction
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Dental PainA Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction
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  1. San Marcos, Texas
  2. Salt Lake City, Utah
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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction
Official Title  ICMJE Not Provided
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Dental Pain
Intervention  ICMJE
  • Drug: ARRY-371797, p38 inhibitor; oral
    dose 1, dose 2
  • Drug: Placebo; oral
    dose 1, dose 2
  • Drug: Placebo; oral
    dose 1
  • Drug: ARRY-371797, p38 inhibitor; oral
    dose 2
Study Arms  ICMJE
  • Experimental: ARRY-371797
    Intervention: Drug: ARRY-371797, p38 inhibitor; oral
  • Experimental: Placebo, ARRY-371797
    Interventions:
    • Drug: Placebo; oral
    • Drug: ARRY-371797, p38 inhibitor; oral
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo; 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: January 6, 2012)
103
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2007)
150
Actual Study Completion Date  ICMJE February 11, 2008
Actual Primary Completion Date February 11, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT00542035
Other Study ID Numbers  ICMJE ARRAY-797-221
Has Data Monitoring Committee No
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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2020

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