Study of Diclofenac Capsules to Treat Osteoarthritis Pain

Summary

The purpose of this study is to determine whether Diclofenac \[Test\] Capsules are safe and effective for the treatment of osteoarthritis pain of the hip or knee.

Conditions

• Osteoarthritis

Interventions

DRUG

Diclofenac

35 mg bid Capsules

DRUG

Diclofenac

35 mg tid Capsules

DRUG

Placebo

Capsules

Sponsors & Collaborators

• Iroko Pharmaceuticals, LLC

  lead INDUSTRY

Principal Investigators

• John M Agaiby, MD · Clinical Investigation Specialists, Inc

• Eddie Armas, MD · Well Pharma Medical Research, Corporation

• Matthew Barton, MD · Office of Matthew Barton, MD

• David Bouda, MD · Heartland Clinical Research, Inc

• Venkata Challa, MD · Peters Medical Research

• John Champlin, MD · Med Center

• Francisco Chevres, MD · Pinnacle Trials, Inc

• Melanie Christina, MD · Clinical Investigations of Texas, LLC

• James R Clark, MD · Charlottesville Medical Research Center, LLC

• Stephen Daniels, DO · Premier Research Group - Austin

• Richard R Eckert, MD · Hypothetest, LLC

• Brandon Essink, MD · Meridian Clinical Research

• Richard M Glover, MD · Heartland Research Associates, LLC

• Kent S Hoffman, DO · Alliance Clinical Research

• Curtis S Horn, MD · Quality Research Inc

• Raymond E Jackson, MD · Quest Research Institute

• Jeffry Jacqmein, MD · Jacksonville Center For Clinical Research

• Enrico Jones, MD · Triad Clinical Research

• Alan Kivitz, MD · Altoona Center for Clinical Research

• Kevin Kuettel, MD · ACRI-Phase I, LLC

• Gregory F Lakin, DO · Professional Research Network of Kansas, LLC

• Theresia Lee, MD · Progressive Clinical Research

• Sathish Modugu, MD · Drug Trials America

• Julie A Mullen, DO · Sterling Research Group, Ltd

• Kashyap Patel, MD · Peninsula Research, Inc

• Kyle Patrick, DO · Premier Research Group - Phoenix

• Antoinette A Pragalos, MD · Community Research

• Larry D Reed, MD, PhD · Healthcare Research

• Eli M Roth, MD · Sterling Research Group, Ltd

• Douglas R Schumacher, MD · Radiant Research, Inc

• Mark Stich, DO · Westside Center for Clinical Research

• Bradley Swenson, MD · Radiant Research, Inc

• Marvin Tark, MD · Drug Studies America

• Gary Tarshis, MD · Expresscare Clinical Research

• Haydn M Thomas, MD · Clinical Trials Technology Inc

• Cindy Tuten, MD · Clinical Study Center of Asheville, LLC

• Larkin T Wadsworth, MD · Sundance Clinical Research, LLC

• Robert J Wagner, MD · Community Research

• Larry S Watkins, MD · Lynn Institute of the Ozarks

• Tamela Zimmerman, MD · Community Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-10-31

Primary Completion

2012-03-31

Completion

2012-10-31

Countries

• United States

Study Locations