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

February 17, 2021 updated by: Pfizer

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP ANALGESIC EFFICACY TRIAL OF ORAL ARRY-371797 IN SUBJECTS UNDERGOING THIRD MOLAR EXTRACTION

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Marcos, Texas, United States, 78666
        • Scirex Research Center
    • Utah
      • Salt Lake City, Utah, United States, 84117
        • Scirex Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo; oral
dose 1, dose 2
Drug: Placebo; oral
dose 1
Experimental: ARRY-371797
Drug: ARRY-371797, p38 inhibitor; oral
dose 1, dose 2
Drug: ARRY-371797, p38 inhibitor; oral
dose 2
Experimental: Placebo, ARRY-371797
Drug: ARRY-371797, p38 inhibitor; oral
dose 1, dose 2
Drug: ARRY-371797, p38 inhibitor; oral
dose 2
Drug: Placebo; oral
dose 1, dose 2
Drug: Placebo; oral
dose 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Duration of study

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2007

Primary Completion (Actual)

February 11, 2008

Study Completion (Actual)

February 11, 2008

Study Registration Dates

First Submitted

October 5, 2007

First Submitted That Met QC Criteria

October 5, 2007

First Posted (Estimate)

October 10, 2007

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARRAY-797-221
  • C4411008 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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