Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain
NCT ID: NCT01510912
Last Updated: 2014-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
602 participants
INTERVENTIONAL
2012-01-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Diclofenac Capsules 35 mg bid or tid
Diclofenac
35 mg bid or tid Capsules
Interventions
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Diclofenac
35 mg bid or tid Capsules
Eligibility Criteria
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Inclusion Criteria
* If a participant in the previous DIC3-08-05 study, completed the study and did not discontinue for lack of efficacy or safety
* Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain
* Is a current chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for his/her OA pain and is anticipated to benefit from continuous treatment with therapeutic doses of NSAIDs. A current chronic user is defined as a subject who has used these treatments for ≥ \[greater than or equal to\] 20 days of the last 30 days before screening
Exclusion Criteria
* Requires chronic use of opioid or opioid combination products to control OA pain of the knee or hip
* Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease
* Has significant difficulties swallowing capsules or is unable to tolerate oral medication
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 Medical Research, Corporation
Matthew Barton, MD
Role: PRINCIPAL_INVESTIGATOR
Office of Matthew Barton, MD
David Bouda, MD
Role: PRINCIPAL_INVESTIGATOR
Heartland Clinical Research
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
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
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
Marvin Tark, MD
Role: PRINCIPAL_INVESTIGATOR
Drug Studies America
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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Altman RD, Strand V, Hochberg MC, Gibofsky A, Markenson JA, Hopkins WE, Cryer B, Kivitz A, Nezzer J, Imasogie O, Young CL. Low-dose SoluMatrix diclofenac in the treatment of osteoarthritis: A 1-year, open-label, Phase III safety study. Postgrad Med. 2015 Jun;127(5):517-28. doi: 10.1080/00325481.2015.1040716. Epub 2015 Apr 27.
Other Identifiers
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DIC3-08-06
Identifier Type: -
Identifier Source: org_study_id
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