Clinical trial NCT01366014: A Study of ARRY-371797 in Patients With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis
knee
pain
NSAID
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-06-03
Enrollment: 157
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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).
timeFrame: 4 weeks
Secondary outcomes:
measure: 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).
timeFrame: 4 weeks
measure: Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs.
timeFrame: 5 weeks
measure: Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Fort Lauderdale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pinellas Park
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Watertown
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Olive Branch
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Duncansville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Kenosha
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: