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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

Placebo; oral

ARRY-371797, p38 inhibitor; oral

Celecoxib, COX-2 inhibitor; oral

Placebo; oral

ARRY-371797, p38 inhibitor; oral

About this trial

This is an interventional treatment trial for Dental Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

PPD Phase I Clinic
Lifetree Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Active Comparator

Experimental

Arm Label

Placebo

Placebo, ARRY-371797

ARRY-371797, Placebo

ARRY-371797

Celecoxib, Placebo

Celecoxib, ARRY-371797

Arm Description

Outcomes

Primary Outcome Measures

Assess the efficacy of the study drug dosed postoperatively in terms of total pain relief (TOTPAR).

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

Secondary Outcome Measures

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].

Full Information

NCT ID

NCT00663767

First Posted

April 18, 2008

Last Updated

February 7, 2021

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00663767

Brief Title

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

Official Title

A Randomized, Double-blind, Placebo- and Active-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

April 7, 2008 (Actual)

Primary Completion Date

June 20, 2008 (Actual)

Study Completion Date

June 20, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

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 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.

6. Conditions and Keywords

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

Dental Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

250 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Placebo, ARRY-371797

Arm Type

Experimental

Arm Title

ARRY-371797, Placebo

Arm Type

Experimental

Arm Title

ARRY-371797

Arm Type

Experimental

Arm Title

Celecoxib, Placebo

Arm Type

Active Comparator

Arm Title

Celecoxib, ARRY-371797

Arm Type

Experimental

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 1: multiple dose levels

Intervention Type

Drug

Intervention Name(s)

ARRY-371797, p38 inhibitor; oral

Intervention Description

dose 1: multiple dose levels; dose 2

Intervention Type

Drug

Intervention Name(s)

Celecoxib, COX-2 inhibitor; oral

Intervention Description

dose 1

Intervention Type

Drug

Intervention Name(s)

Placebo; oral

Intervention Description

dose 2

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 postoperatively in terms of total pain relief (TOTPAR).

Time Frame

6 hours post-dose

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

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

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

PPD Phase I Clinic

City

Austin

State/Province

Texas

ZIP/Postal Code

78744

Country

United States

Facility Name

Lifetree Clinical Research

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84106

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

Links:

URL

http://medicine.iupui.edu/flockhart/table.htm

Description

Related Info

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

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