A Study of ARRY-371797 in Patients With Osteoarthritis of the Knee
2 other identifiers
interventional
157
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2011
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 2, 2011
CompletedFirst Posted
Study publicly available on registry
June 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedOctober 14, 2020
October 1, 2020
1 year
June 2, 2011
October 6, 2020
Conditions
Keywords
Outcome Measures
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).
4 weeks
Secondary Outcomes (3)
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
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs.
5 weeks
Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations.
4 weeks
Study Arms (3)
ARRY-371797
EXPERIMENTALOxycodone HCl ER
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
multiple dose, single schedule
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (13)
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Fort Lauderdale, Florida, 33316, United States
Pfizer Investigational Site
Pinellas Park, Florida, 33781, United States
Pfizer Investigational Site
Sarasota, Florida, 34232, United States
Pfizer Investigational Site
Watertown, Massachusetts, United States
Pfizer Investigational Site
Olive Branch, Mississippi, 38654, United States
Pfizer Investigational Site
Charlotte, North Carolina, United States
Pfizer Investigational Site
Raleigh, North Carolina, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635, United States
Pfizer Investigational Site
Austin, Texas, United States
Pfizer Investigational Site
Salt Lake City, Utah, United States
Pfizer Investigational Site
Kenosha, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2011
First Posted
June 3, 2011
Study Start
June 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
October 14, 2020
Record last verified: 2020-10