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
  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:


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

  Hide Study Locations
Locations
United States, Arizona
Premier Research Group - Phoenix
Phoenix, Arizona, United States, 85027
United States, Arkansas
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States, 72205
United States, California
Acri-Phase I, LLC
Anaheim, California, United States, 92801
Med Center
Carmichael, California, United States, 95608
United States, Colorado
Expresscare Clinical Research
Colorado Springs, Colorado, United States, 80909
United States, Florida
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Westside Center for Clinical Research
Jacksonville, Florida, United States, 32205
Well Pharma Medical Research, Corporation
Miami, Florida, United States, 33143
Peninsula Research, Inc
Ormond Beach, Florida, United States, 32174
Alliance Clinical Research
Winter Park, Florida, United States, 32792
United States, Georgia
Pinnacle Trials, Inc
Atlanta, Georgia, United States, 30329
Drug Studies America
Marietta, Georgia, United States, 30060
United States, Illinois
Clinical Investigation Specialists, Inc
Gurnee, Illinois, United States, 60031
United States, Kansas
Heartland Research Associates, LLC
Newton, Kansas, United States, 67114
Clinical Trials Technology Inc
Prairie Village, Kansas, United States, 66206
Professional Research Network of Kansas, LLC
Wichita, Kansas, United States, 67203
United States, Kentucky
Community Research
Crestview Hills, Kentucky, United States, 41017
United States, Michigan
Quest Research Institute
Bingham Farms, Michigan, United States, 48025
United States, Missouri
Healthcare Research
Florissant, Missouri, United States, 63031
Sundance Clinical Research, LLC
St Louis, Missouri, United States, 63141
United States, Nebraska
Heartland Clinical Research, Inc
Omaha, Nebraska, United States, 68134
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
United States, Nevada
Office of Matthew Barton, MD
Las Vegas, Nevada, United States, 89106
United States, New York
Drug Trials America
Hartsdale, New York, United States, 10530
United States, North Carolina
Clinical Study Center of Asheville, LLC
Asheville, North Carolina, United States, 28803
Triad Clinical Research
Greensboro, North Carolina, United States, 27408
Peters Medical Research
High Point, North Carolina, United States, 27262
United States, Ohio
Sterling Research Group, Ltd
Cincinnati, Ohio, United States, 45246
Sterling Research Group, Ltd
Cincinnati, Ohio, United States, 45219
Community Research
Cincinnati, Ohio, United States, 45227
Community Research
Cincinnati, Ohio, United States, 45245
Radiant Research, Inc
Columbus, Ohio, United States, 43212
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Radiant Research, Inc
Anderson, South Carolina, United States, 29621
United States, Texas
Premier Research Group - Austin
Austin, Texas, United States, 78705
Clinical Investigations of Texas, LLC
Plano, Texas, United States, 75075
Quality Research Inc
San Antonio, Texas, United States, 78209
Progressive Clinical Research
San Antonio, Texas, United States, 78229
United States, Virginia
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, United States, 22911
Hypothetest, LLC
Roanoke, Virginia, United States, 24018
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 April 16, 2014