Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain

A Multicenter, Open-Label, Safety Study of Diclofenac [Test] Capsules in Subjects With Osteoarthritis of the Knee or Hip

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: Diclofenac

• Study Type: Interventional
• Enrollment (Actual): 602
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 30 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diclofenac Capsules 35 mg bid or tid	Drug: Diclofenac; 35 mg bid or tid Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination	The safety of Diclofenac 35 mg capsules was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, and serious adverse events.	Baseline to Week 52/Early Termination

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Short Form-36 Physical Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET	The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The physical component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability.	Baseline to Week 52/Early Termination
Mean Short Form-36 Mental Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET	The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The mental component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability.	Baseline to Week 52/Early Termination

Collaborators and Investigators

• Sponsor: Iroko Pharmaceuticals, LLC
• Investigators: Principal Investigator: Alan Kivitz, MD, Altoona Center for Clinical Research; Principal Investigator: Jeffry Jacqmein, MD, Jacksonville Center for Clinical Research; Principal Investigator: Larkin T Wadsworth, MD, Sundance Clinical Research, LLC; Principal Investigator: Matthew Barton, MD, Office of Matthew Barton, MD; 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: Curtis S Horn, MD, Quality Research Inc; Principal Investigator: Gregory F Lakin, DO, Professional Research Network of Kansas, LLC; Principal Investigator: Sathish Modugu, MD, Drug Trials America; Principal Investigator: Kashyap Patel, MD, Peninsula Research, Inc; Principal Investigator: Douglas R Schumacher, MD, Radiant Research, Inc; Principal Investigator: Mark Stich, DO, Westside Center for Clinical Research; Principal Investigator: Haydn M Thomas, MD, Clinical Trials Technology Inc; Principal Investigator: Robert J Wagner, MD, Community Research; Principal Investigator: John M Agaiby, MD, Clinical Investigation Specialists, 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: Kent S Hoffman, DO, Alliance Clinical Research; Principal Investigator: Raymond E Jackson, MD, Quest Research Institute; Principal Investigator: Enrico Jones, MD, Triad Clinical Research; Principal Investigator: Kevin Kuettel, MD, Acri-Phase I, LLC; Principal Investigator: Theresia Lee, MD, Progressive Clinical Research; Principal Investigator: Julie A Mullen, DO, Sterling Research Group, Ltd; Principal Investigator: Kyle Patrick, DO, Premier Research Group - Phoenix; Principal Investigator: Antoinette A Pragalos, MD, Community Research; Principal Investigator: Eli M Roth, MD, Sterling Research Group, Ltd; 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: Cindy Tuten, MD, Clinical Study Center of Asheville, LLC; Principal Investigator: Larry S Watkins, MD, Lynn Institute of the Ozarks; Principal Investigator: Tamela Zimmerman, MD, Community Research; Principal Investigator: Eddie Armas, MD, Well Pharma Medical Medical Research, Corporation; Principal Investigator: David Bouda, MD, Heartland Clinical Research; Principal Investigator: Larry D Reed, MD, HealthCare Research

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: January 12, 2012
• First Submitted That Met QC Criteria: January 17, 2012
• First Posted (Estimate): January 18, 2012

Study Record Updates

• Last Update Posted (Estimate): May 9, 2014
• Last Update Submitted That Met QC Criteria: April 8, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: DIC3-08-06