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: April 29, 2014
Last verified: April 2014
  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:
  • 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. [ Time Frame: Baseline to Week 12/Early Termination ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • 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. [ Time Frame: Baseline to Week 2 ] [ Designated as safety issue: No ]

    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.


  • 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. [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]

    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.


  • 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. [ Time Frame: Baseline to Week 12/Early Termination ] [ Designated as safety issue: No ]

    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.


  • 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. [ Time Frame: Baseline to Week 12/Early Termination ] [ Designated as safety issue: No ]

    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.


  • 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. [ Time Frame: Baseline to Week 12/Early Termination ] [ Designated as safety issue: No ]

    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.



Enrollment: 305
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 Capsules 35 mg bid Drug: Diclofenac
35 mg bid Capsules
Experimental: Diclofenac Capsules 35 mg tid Drug: Diclofenac
35 mg tid Capsules
Placebo Comparator: Placebo Capsule Drug: Placebo
Capsules

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: March 12, 2014
Last Updated: April 29, 2014
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 July 20, 2014