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

NCT01366014 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2020-10-14

No results posted yet for this study

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.

Conditions

  • Osteoarthritis of the Knee

Interventions

DRUG

ARRY-371797, p38 inhibitor; oral

multiple dose, single schedule

DRUG

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

multiple dose, single schedule

DRUG

Placebo; oral

matching placebo

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01366014 on ClinicalTrials.gov