search
Back to results

A Study of ARRY-371797 in Patients With Osteoarthritis of the Knee

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ARRY-371797, p38 inhibitor; oral
Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral
Placebo; oral
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring osteoarthritis, knee, pain, NSAID

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Diagnosis of OA of the knee, based on American College of Rheumatology (ACR) criteria, confirmed by X-ray (K-L Grade II/III within the last year).
  • At least moderate or severe pain due to OA in one knee.
  • On nonsteroidal anti-inflammatory drug (NSAID) 28 days previous to study start and willing to continue on NSAID throughout study.
  • Discontinuation of opioids prior to study start.
  • Additional criteria exist.

Key Exclusion Criteria:

  • Current or recent infection in the last 7 days; infection requiring hospitalization or parenteral antibiotics within the last 6 months; history of or currently active tuberculosis, hepatitis B or C, or human immunodeficiency virus (HIV).
  • Surgery on the index knee within the previous 6 months.
  • Trauma or other surgeries within the previous 8 weeks.
  • Specific abnormal laboratory values or electrocardiogram abnormalities.
  • Gastrointestinal surgery that may interfere with motility or absorption.
  • On non-stable dose of bisphosphonates, or any prior denosumab or parathyroid hormone (PTH) therapies.
  • Prior parenteral tumor necrosis factor (TNF) inhibitor or anti-nerve growth factor (NGF) therapies.
  • Intramuscular, intravenous or oral corticosteroids within the previous 6 weeks.
  • Intra-articular corticosteroids in the index knee within the previous 8 weeks or viscosupplementation in the index knee within the previous 4 months.
  • Currently enrolled in or participated in another clinical trial within the previous 3 months.
  • Additional criteria exist.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

ARRY-371797

Oxycodone HCl ER

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Assess the efficacy of the study drug (versus placebo) in terms of change from baseline to week 4 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score (index knee).

Secondary Outcome Measures

Assess the efficacy of the study drug (versus placebo) in terms of change from baseline to week 4 in the WOMAC stiffness and physical function subscale scores (index knee).
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs.
Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations.

Full Information

First Posted
June 2, 2011
Last Updated
October 6, 2020
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT01366014
Brief Title
A Study of ARRY-371797 in Patients With Osteoarthritis of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a Phase 2 study, involving a 4-week treatment period, designed to test the ability of investigational study drug ARRY-371797 to reduce pain in patients with moderate to severe pain due to osteoarthritis (OA) of the knee, and to further evaluate the drug's safety. Approximately 150 patients 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
Osteoarthritis of the Knee
Keywords
osteoarthritis, knee, pain, NSAID

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARRY-371797
Arm Type
Experimental
Arm Title
Oxycodone HCl ER
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ARRY-371797, p38 inhibitor; oral
Intervention Description
multiple dose, single schedule
Intervention Type
Drug
Intervention Name(s)
Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral
Intervention Description
multiple dose, single schedule
Intervention Type
Drug
Intervention Name(s)
Placebo; oral
Intervention Description
matching placebo
Primary Outcome Measure Information:
Title
Assess the efficacy of the study drug (versus placebo) in terms of change from baseline to week 4 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score (index knee).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Assess the efficacy of the study drug (versus placebo) in terms of change from baseline to week 4 in the WOMAC stiffness and physical function subscale scores (index knee).
Time Frame
4 weeks
Title
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs.
Time Frame
5 weeks
Title
Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Diagnosis of OA of the knee, based on American College of Rheumatology (ACR) criteria, confirmed by X-ray (K-L Grade II/III within the last year). At least moderate or severe pain due to OA in one knee. On nonsteroidal anti-inflammatory drug (NSAID) 28 days previous to study start and willing to continue on NSAID throughout study. Discontinuation of opioids prior to study start. Additional criteria exist. Key Exclusion Criteria: Current or recent infection in the last 7 days; infection requiring hospitalization or parenteral antibiotics within the last 6 months; history of or currently active tuberculosis, hepatitis B or C, or human immunodeficiency virus (HIV). Surgery on the index knee within the previous 6 months. Trauma or other surgeries within the previous 8 weeks. Specific abnormal laboratory values or electrocardiogram abnormalities. Gastrointestinal surgery that may interfere with motility or absorption. On non-stable dose of bisphosphonates, or any prior denosumab or parathyroid hormone (PTH) therapies. Prior parenteral tumor necrosis factor (TNF) inhibitor or anti-nerve growth factor (NGF) therapies. Intramuscular, intravenous or oral corticosteroids within the previous 6 weeks. Intra-articular corticosteroids in the index knee within the previous 8 weeks or viscosupplementation in the index knee within the previous 4 months. Currently enrolled in or participated in another clinical trial within the previous 3 months. 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
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Pfizer Investigational Site
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Pfizer Investigational Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Pfizer Investigational Site
City
Watertown
State/Province
Massachusetts
Country
United States
Facility Name
Pfizer Investigational Site
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Pfizer Investigational Site
City
Kenosha
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study of ARRY-371797 in Patients With Osteoarthritis of the Knee

We'll reach out to this number within 24 hrs