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

Osteoarthritis of the Knee Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366014
• Other study ID #: ARRAY-797-223
• Secondary ID: C4411007
• Status: Completed
• Phase: Phase 2
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: October 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• ARRY-371797, p38 inhibitor; oral
multiple dose, single schedule
• Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral
multiple dose, single schedule
• Placebo; oral
matching placebo

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Duncansville	Pennsylvania
United States	Pfizer Investigational Site	Fort Lauderdale	Florida
United States	Pfizer Investigational Site	Kenosha	Wisconsin
United States	Pfizer Investigational Site	Olive Branch	Mississippi
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Pinellas Park	Florida
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	Sarasota	Florida
United States	Pfizer Investigational Site	Watertown	Massachusetts
United States	Pfizer Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		4 weeks
Secondary	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).		4 weeks
Secondary	Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs.		5 weeks
Secondary	Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations.		4 weeks