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

October 6, 2020 updated by: Pfizer
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

157

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
    • Arizona
      • Phoenix, Arizona, United States
        • Pfizer Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Pfizer Investigational Site
      • Pinellas Park, Florida, United States, 33781
        • Pfizer Investigational Site
      • Sarasota, Florida, United States, 34232
        • Pfizer Investigational Site
    • Massachusetts
      • Watertown, Massachusetts, United States
        • Pfizer Investigational Site
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Pfizer Investigational Site
      • Raleigh, North Carolina, United States
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States
        • Pfizer Investigational Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States
        • Pfizer Investigational Site
    • Wisconsin
      • Kenosha, Wisconsin, United States
        • Pfizer Investigational Site

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

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo; oral
matching placebo
Experimental: ARRY-371797
Drug: ARRY-371797, p38 inhibitor; oral
multiple dose, single schedule
Active Comparator: Oxycodone HCl ER
Drug: Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral
multiple dose, single schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
4 weeks
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs.
Time Frame: 5 weeks
5 weeks
Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations.
Time Frame: 4 weeks
4 weeks

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

June 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

June 2, 2011

First Submitted That Met QC Criteria

June 2, 2011

First Posted (Estimate)

June 3, 2011

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARRAY-797-223
  • C4411007 (Other Identifier: Pfizer)

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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