Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01510912
First received: January 12, 2012
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to evaluate the safety of Diclofenac [Test] Capsules for the treatment of osteoarthritis pain of the knee or hip.


Condition Intervention Phase
Osteoarthritis
Drug: Diclofenac
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Safety Study of Diclofenac [Test] Capsules in Subjects With Osteoarthritis of the Knee or Hip

Resource links provided by NLM:


Further study details as provided by Iroko Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: ~53 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: January 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Diclofenac
    Capsules (35 mg BID and TID); 52-week treatment period
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female ≥ [greater than or equal to] 40 years of age
  • 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 days before screening

Exclusion Criteria:

  • Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nonsteroid anti-inflammatory drugs (NSAIDs), including diclofenac
  • Requires continuous 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510912

  Show 40 Study Locations
Sponsors and Collaborators
Iroko Pharmaceuticals, LLC
Investigators
Principal Investigator: John M Agaiby, MD Clinical Investigation Specialists, Inc
Principal Investigator: Eddie Armas, MD Well Pharma Medical Medical Research, Corporation
Principal Investigator: Matthew Barton, MD Office of Matthew Barton, MD
Principal Investigator: David Bouda, MD Heartland Clinical Research
Principal Investigator: Venkata Challa, MD Peters Medical Research
Principal Investigator: John Champlin, MD Med Center
Principal Investigator: Francisco Chevres, MD Pinnacle Trials, Inc
Principal Investigator: Melanie Christina, MD Clinical Investigations of Texas, LLC
Principal Investigator: James R Clark, MD Charlottesville Medical Research Center, LLC
Principal Investigator: Stephen Daniels, DO Premier Research Group - Austin
Principal Investigator: Richard R Eckert, MD Hypothetest, LLC
Principal Investigator: Brandon Essink, MD Meridian Clinical Research
Principal Investigator: Richard M Glover, MD Heartland Research Associates, LLC
Principal Investigator: Kent S Hoffman, DO Alliance Clinical Research
Principal Investigator: Curtis S Horn, MD Quality Research Inc
Principal Investigator: Raymond E Jackson, MD Quest Research Institute
Principal Investigator: Jeffry Jacqmein, MD Jacksonville Center for Clinical Research
Principal Investigator: Enrico Jones, MD Triad Clinical Research
Principal Investigator: Alan Kivitz, MD Altoona Center for Clinical Research
Principal Investigator: Kevin Kuettel, MD Acri-Phase I, LLC
Principal Investigator: Gregory F Lakin, DO Professional Research Network of Kansas, LLC
Principal Investigator: Theresia Lee, MD Progressive Clinical Research
Principal Investigator: Sathish Modugu, MD Drug Trials America
Principal Investigator: Julie A Mullen, DO Sterling Research Group, Ltd
Principal Investigator: Kashyap Patel, MD Peninsula Research, Inc
Principal Investigator: Kyle Patrick, DO Premier Research Group - Phoenix
Principal Investigator: Antoinette A Pragalos, MD Community Research
Principal Investigator: Larry D Reed, MD Healthcare Research
Principal Investigator: Eli M Roth, MD Sterling Research Group, Ltd
Principal Investigator: Douglas R Schumacher, MD Radiant Research, Inc
Principal Investigator: Mark Stich, DO Westside Center for Clinical Research
Principal Investigator: Bradley Swenson, MD Radiant Research, Inc
Principal Investigator: Gary Tarshis, MD Expresscare Clinical Research
Principal Investigator: Haydn M Thomas, MD Clinical Trials Technology Inc
Principal Investigator: Cindy Tuten, MD Clinical Study Center of Asheville, LLC
Principal Investigator: Larkin T Wadsworth, MD Sundance Clinical Research, LLC
Principal Investigator: Robert J Wagner, MD Community Research
Principal Investigator: Larry S Watkins, MD Lynn Institute of the Ozarks
Principal Investigator: Tamela Zimmerman, MD Community Research
Principal Investigator: Marvin Tark, MD Drug Studies America
  More Information

No publications provided

Responsible Party: Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01510912     History of Changes
Other Study ID Numbers: DIC3-08-06
Study First Received: January 12, 2012
Last Updated: September 18, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 22, 2014