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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ARRY-371797

Group Type EXPERIMENTAL

ARRY-371797, p38 inhibitor; oral

Intervention Type DRUG

multiple dose, single schedule

Oxycodone HCl ER

Group Type ACTIVE_COMPARATOR

Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral

Intervention Type DRUG

multiple dose, single schedule

Placebo

Group Type PLACEBO_COMPARATOR

Placebo; oral

Intervention Type DRUG

matching placebo

Interventions

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ARRY-371797, p38 inhibitor; oral

multiple dose, single schedule

Intervention Type DRUG

Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral

multiple dose, single schedule

Intervention Type DRUG

Placebo; oral

matching placebo

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No