Study of Diclofenac Capsules to Treat Osteoarthritis Pain
NCT ID: NCT01461369
Last Updated: 2014-05-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
305 participants
INTERVENTIONAL
2011-10-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Diclofenac Capsules 35 mg bid
Diclofenac
35 mg bid Capsules
Diclofenac Capsules 35 mg tid
Diclofenac
35 mg tid Capsules
Placebo Capsule
Placebo
Capsules
Interventions
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Diclofenac
35 mg bid Capsules
Diclofenac
35 mg tid Capsules
Placebo
Capsules
Eligibility Criteria
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Inclusion Criteria
* Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for OA pain
* Discontinued all analgesic therapy at Screening
* For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
Exclusion Criteria
* Requires continuous use of opioid or opioid combination products to control OA pain of the knee or hip
* Clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease
* Significant difficulties swallowing capsules or unable to tolerate oral medication
* Previous participation in another clinical study of Diclofenac Capsules or received any investigational drug or device or investigational therapy within 30 days before Screening.
40 Years
ALL
No
Sponsors
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Iroko Pharmaceuticals, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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John M Agaiby, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Investigation Specialists, Inc
Eddie Armas, MD
Role: PRINCIPAL_INVESTIGATOR
Well Pharma Medical Research, Corporation
Matthew Barton, MD
Role: PRINCIPAL_INVESTIGATOR
Office of Matthew Barton, MD
David Bouda, MD
Role: PRINCIPAL_INVESTIGATOR
Heartland Clinical Research, Inc
Venkata Challa, MD
Role: PRINCIPAL_INVESTIGATOR
Peters Medical Research
John Champlin, MD
Role: PRINCIPAL_INVESTIGATOR
Med Center
Francisco Chevres, MD
Role: PRINCIPAL_INVESTIGATOR
Pinnacle Trials, Inc
Melanie Christina, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Investigations of Texas, LLC
James R Clark, MD
Role: PRINCIPAL_INVESTIGATOR
Charlottesville Medical Research Center, LLC
Stephen Daniels, DO
Role: PRINCIPAL_INVESTIGATOR
Premier Research Group - Austin
Richard R Eckert, MD
Role: PRINCIPAL_INVESTIGATOR
Hypothetest, LLC
Brandon Essink, MD
Role: PRINCIPAL_INVESTIGATOR
Meridian Clinical Research
Richard M Glover, MD
Role: PRINCIPAL_INVESTIGATOR
Heartland Research Associates, LLC
Kent S Hoffman, DO
Role: PRINCIPAL_INVESTIGATOR
Alliance Clinical Research
Curtis S Horn, MD
Role: PRINCIPAL_INVESTIGATOR
Quality Research Inc
Raymond E Jackson, MD
Role: PRINCIPAL_INVESTIGATOR
Quest Research Institute
Jeffry Jacqmein, MD
Role: PRINCIPAL_INVESTIGATOR
Jacksonville Center For Clinical Research
Enrico Jones, MD
Role: PRINCIPAL_INVESTIGATOR
Triad Clinical Research
Alan Kivitz, MD
Role: PRINCIPAL_INVESTIGATOR
Altoona Center for Clinical Research
Kevin Kuettel, MD
Role: PRINCIPAL_INVESTIGATOR
ACRI-Phase I, LLC
Gregory F Lakin, DO
Role: PRINCIPAL_INVESTIGATOR
Professional Research Network of Kansas, LLC
Theresia Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Progressive Clinical Research
Sathish Modugu, MD
Role: PRINCIPAL_INVESTIGATOR
Drug Trials America
Julie A Mullen, DO
Role: PRINCIPAL_INVESTIGATOR
Sterling Research Group, Ltd
Kashyap Patel, MD
Role: PRINCIPAL_INVESTIGATOR
Peninsula Research, Inc
Kyle Patrick, DO
Role: PRINCIPAL_INVESTIGATOR
Premier Research Group - Phoenix
Antoinette A Pragalos, MD
Role: PRINCIPAL_INVESTIGATOR
Community Research
Larry D Reed, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Healthcare Research
Eli M Roth, MD
Role: PRINCIPAL_INVESTIGATOR
Sterling Research Group, Ltd
Douglas R Schumacher, MD
Role: PRINCIPAL_INVESTIGATOR
Radiant Research, Inc
Mark Stich, DO
Role: PRINCIPAL_INVESTIGATOR
Westside Center for Clinical Research
Bradley Swenson, MD
Role: PRINCIPAL_INVESTIGATOR
Radiant Research, Inc
Marvin Tark, MD
Role: PRINCIPAL_INVESTIGATOR
Drug Studies America
Gary Tarshis, MD
Role: PRINCIPAL_INVESTIGATOR
Expresscare Clinical Research
Haydn M Thomas, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Trials Technology Inc
Cindy Tuten, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Study Center of Asheville, LLC
Larkin T Wadsworth, MD
Role: PRINCIPAL_INVESTIGATOR
Sundance Clinical Research, LLC
Robert J Wagner, MD
Role: PRINCIPAL_INVESTIGATOR
Community Research
Larry S Watkins, MD
Role: PRINCIPAL_INVESTIGATOR
Lynn Institute of the Ozarks
Tamela Zimmerman, MD
Role: PRINCIPAL_INVESTIGATOR
Community Research
Locations
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Premier Research Group - Phoenix
Phoenix, Arizona, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Acri-Phase I, LLC
Anaheim, California, United States
Med Center
Carmichael, California, United States
Expresscare Clinical Research
Colorado Springs, Colorado, United States
Westside Center for Clinical Research
Jacksonville, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Well Pharma Medical Research, Corporation
Miami, Florida, United States
Peninsula Research, Inc
Ormond Beach, Florida, United States
Alliance Clinical Research
Winter Park, Florida, United States
Pinnacle Trials, Inc
Atlanta, Georgia, United States
Drug Studies America
Marietta, Georgia, United States
Clinical Investigation Specialists, Inc
Gurnee, Illinois, United States
Heartland Research Associates, LLC
Newton, Kansas, United States
Clinical Trials Technology Inc
Prairie Village, Kansas, United States
Professional Research Network of Kansas, LLC
Wichita, Kansas, United States
Community Research
Crestview Hills, Kentucky, United States
Quest Research Institute
Bingham Farms, Michigan, United States
Healthcare Research
Florissant, Missouri, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
Heartland Clinical Research, Inc
Omaha, Nebraska, United States
Meridian Clinical Research
Omaha, Nebraska, United States
Office of Matthew Barton, MD
Las Vegas, Nevada, United States
Drug Trials America
Hartsdale, New York, United States
Clinical Study Center of Asheville, LLC
Asheville, North Carolina, United States
Triad Clinical Research
Greensboro, North Carolina, United States
Peters Medical Research
High Point, North Carolina, United States
Sterling Research Group, Ltd
Cincinnati, Ohio, United States
Community Research
Cincinnati, Ohio, United States
Community Research
Cincinnati, Ohio, United States
Sterling Research Group, Ltd
Cincinnati, Ohio, United States
Radiant Research, Inc
Columbus, Ohio, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Radiant Research, Inc
Anderson, South Carolina, United States
Premier Research Group - Austin
Austin, Texas, United States
Clinical Investigations of Texas, LLC
Plano, Texas, United States
Quality Research Inc
San Antonio, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, United States
Hypothetest, LLC
Roanoke, Virginia, United States
Countries
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References
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Gibofsky A, Hochberg MC, Jaros MJ, Young CL. Efficacy and safety of low-dose submicron diclofenac for the treatment of osteoarthritis pain: a 12 week, phase 3 study. Curr Med Res Opin. 2014 Sep;30(9):1883-93. doi: 10.1185/03007995.2014.946123. Epub 2014 Aug 6.
Other Identifiers
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DIC3-08-05
Identifier Type: -
Identifier Source: org_study_id
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