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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01366014
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : June 14, 2013
Information provided by (Responsible Party):
Array BioPharma

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Drug: ARRY-371797, p38 inhibitor; oral Drug: Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral Drug: Placebo; oral Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : June 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Oxycodone

Arm Intervention/treatment
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

Placebo Comparator: Placebo Drug: Placebo; oral
matching placebo

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01366014

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United States, Arizona
Phoenix, Arizona, United States
United States, Florida
Ft. Lauderdale, Florida, United States, 33316
Pinellas Park, Florida, United States, 33781
Sarasota, Florida, United States, 34232
United States, Massachusetts
Watertown, Massachusetts, United States
United States, Mississippi
Olive Branch, Mississippi, United States, 38654
United States, North Carolina
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Austin, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Wisconsin
Kenosha, Wisconsin, United States
Sponsors and Collaborators
Array BioPharma

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Responsible Party: Array BioPharma Identifier: NCT01366014     History of Changes
Other Study ID Numbers: ARRAY-797-223
First Posted: June 3, 2011    Key Record Dates
Last Update Posted: June 14, 2013
Last Verified: June 2013

Keywords provided by Array BioPharma:

Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents