Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain
This study is ongoing, but not recruiting participants.
Sponsor:
Iroko Pharmaceuticals, LLC
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01510912
First received: January 12, 2012
Last updated: April 4, 2012
Last verified: April 2012
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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:
- Incidence of adverse events [ Time Frame: ~53 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 600 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Diclofenac
Capsules (35 mg BID and TID); 52-week treatment period
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 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 continuous 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510912
Show 40 Study Locations
Show 40 Study LocationsSponsors 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 |
| Last Updated: | April 4, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee 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 May 19, 2013