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

Primary Purpose

Dental Pain

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ARRY-371797, p38 inhibitor; oral

Placebo; oral

ARRY-371797, p38 inhibitor; oral

About this trial

This is an interventional supportive care trial for Dental Pain focused on measuring Analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

SCIREX Research Center
SCIREX Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

ARRY-371797

Placebo, ARRY-371797

Placebo

Arm Description

Outcomes

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).

Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs.

Secondary Outcome Measures

Compare the efficacy of the study drug dosed perioperatively versus postoperatively in terms of total pain intensity (VAS).

Full Information

NCT ID

NCT00542035

First Posted

October 5, 2007

Last Updated

February 17, 2021

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00542035

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

November 11, 2007 (Actual)

Primary Completion Date

February 11, 2008 (Actual)

Study Completion Date

February 11, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Pain

Keywords

Analgesia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

103 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ARRY-371797

Arm Type

Experimental

Arm Title

Placebo, ARRY-371797

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

ARRY-371797, p38 inhibitor; oral

Intervention Description

dose 1, dose 2

Intervention Type

Drug

Intervention Name(s)

Placebo; oral

Intervention Description

dose 1, dose 2

Intervention Type

Drug

Intervention Name(s)

Placebo; oral

Intervention Description

dose 1

Intervention Type

Drug

Intervention Name(s)

ARRY-371797, p38 inhibitor; oral

Intervention Description

dose 2

Primary Outcome Measure Information:

Title

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

Title

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 Measure Information:

Title

Compare the efficacy of the study drug dosed perioperatively versus postoperatively in terms of total pain intensity (VAS).

Time Frame

Duration of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

SCIREX Research Center

City

San Marcos

State/Province

Texas

ZIP/Postal Code

78666

Country

United States

Facility Name

SCIREX Research Center

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84117

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Learn more about this trial

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

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