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

Purpose

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	Intervention	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Oxycodone Oxycodone hydrochloride

U.S. FDA Resources

Further study details as provided by Array BioPharma:

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). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs. [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment:	157
Study Start Date:	June 2011
Study Completion Date:	June 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	40 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366014

Locations

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

More Information

No publications provided

Responsible Party:	Array BioPharma
ClinicalTrials.gov Identifier:	NCT01366014 History of Changes
Other Study ID Numbers:	ARRAY-797-223
Study First Received:	June 2, 2011
Last Updated:	July 17, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Array BioPharma:

osteoarthritis
knee
pain
NSAID

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Oxycodone
Analgesics, Opioid
Narcotics

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013