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Completed

NCT Number: NCT01366014

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

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.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ARRY-371797, p38 inhibitor; oral

Drug

multiple dose, single schedule

Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral

Drug

multiple dose, single schedule

Placebo; oral

Drug

matching placebo

Primary outcomes

  1. 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 outcomes

  1. 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

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

    Time frame: 5 weeks

  3. Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations.

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 3, 2011
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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