Study of Diclofenac Capsules to Treat Osteoarthritis Pain

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 305
• 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:

• Primary diagnosis of Functional Class I-III OA of the hip or knee with documented osteoarthritis flare at baseline
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.	The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain". The WOMAC pain subscale score difference is calculated as the WOMAC pain subscale score assessed at Week 12 minus the WOMAC pain subscale score assessed at baseline.	Baseline to Week 12/Early Termination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.	The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain". The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 2 minus the WOMAC pain subscale score assessed at baseline.	Baseline to Week 2
Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.	The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain". The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 6 minus the WOMAC pain subscale score assessed at baseline.	Baseline to Week 6
Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.	The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain". The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Weeks 2, 6, and 12 minus the average of the WOMAC pain subscale score assessed at baseline.	Baseline to Week 12/Early Termination
Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total (Composite) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.	Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total (composite) WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing "No Pain, Stiffness, or Difficulty" and 100 mm representing "Extreme Pain, Stiffness, and Difficulty". The total (composite) WOMAC score difference was calculated as the total (composite) WOMAC score assessed at Weeks 2, 6, and 12 minus the total (composite) WOMAC score assessed at baseline.	Baseline to Week 12/Early Termination
Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale.	The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Pain Imaginable". The VAS pain intensity difference is calculated as the average of the VAS pain intensity scores at Weeks 2, 6, and 12 minus the VAS pain intensity at baseline.	Baseline to Week 12/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: David Bouda, MD, Heartland Clinical Research, 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: 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: Larry D Reed, MD, PhD, HealthCare Research; 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: Eddie Armas, MD, Well Pharma Medical Research, Corporation; 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

Publications and helpful links

General Publications

• Gibofsky A, Hochberg MC, Jaros MJ, Young CL. Efficacy and safety of low-dose submicron diclofenac for the treatment of osteoarthritis pain: a 12 week, phase 3 study. Curr Med Res Opin. 2014 Sep;30(9):1883-93. doi: 10.1185/03007995.2014.946123. Epub 2014 Aug 6.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: October 26, 2011
• First Submitted That Met QC Criteria: October 26, 2011
• First Posted (Estimate): October 28, 2011

Study Record Updates

• Last Update Posted (Estimate): May 26, 2014
• Last Update Submitted That Met QC Criteria: April 29, 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: DIC3-08-05