Open-Label 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:
NCT01510912
First received: January 12, 2012
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Drug: Diclofenac
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, 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:
  • Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination [ Time Frame: Baseline to Week 52/Early Termination ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Mean Short Form-36 Physical Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET [ Time Frame: Baseline to Week 52/Early Termination ] [ Designated as safety issue: No ]
    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.

  • Mean Short Form-36 Mental Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET [ Time Frame: Baseline to Week 52/Early Termination ] [ Designated as safety issue: No ]
    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.


Enrollment: 602
Study Start Date: January 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diclofenac Capsules 35 mg bid or tid Drug: Diclofenac
35 mg bid or tid Capsules

  Eligibility

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

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
  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: NCT01510912

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

No publications provided

Responsible Party: Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01510912     History of Changes
Other Study ID Numbers: DIC3-08-06
Study First Received: January 12, 2012
Results First Received: April 8, 2014
Last Updated: April 8, 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 September 29, 2014