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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:
NCT01461369
First received: October 26, 2011
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
 Drug: Diclofenac
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel-Group, Efficacy and Safety Study of Diclofenac [Test] Capsules in Subjects With Osteoarthritis of the Knee or Hip

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Iroko Pharmaceuticals, LLC:

Primary Outcome Measures:
  • The mean change from baseline in the WOMAC pain subscale score. [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 307
Study Start Date: October 2011
Study Completion Date: October 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diclofenac Test Capsules bid (one capsule) Drug: Diclofenac
Capsules
Experimental: Diclofenac Test Capsules tid (one capsule) Drug: Diclofenac
Capsules
Placebo Comparator: Placebo Capsule qid (one capsule) Drug: Placebo
Capsule qid (one capsule)

  Eligibility

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

Inclusion Criteria:

  • Primary diagnosis of Functional Class I-III OA of the hip or knee
  • 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:

  • History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDS, including diclofenac
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461369

  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 Research, Corporation
Principal Investigator: Matthew Barton, MD Office of Matthew Barton, MD
Principal Investigator: David Bouda, MD Heartland Clinical Research, Inc
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, PhD 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: Marvin Tark, MD Drug Studies America
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
  More Information

No publications provided

Responsible Party: Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01461369     History of Changes
Other Study ID Numbers: DIC3-08-05
Study First Received: October 26, 2011
Last Updated: January 29, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
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 May 16, 2013