Study of Diclofenac Capsules to Treat Osteoarthritis Pain
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| ClinicalTrials.gov Identifier: NCT01461369 |
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Recruitment Status :
Completed
First Posted : October 28, 2011
Results First Posted : May 26, 2014
Last Update Posted : May 26, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoarthritis | Drug: Diclofenac Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 305 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, 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 |
| Study Start Date : | October 2011 |
| Actual Primary Completion Date : | March 2012 |
| Actual Study Completion Date : | October 2012 |
| Arm | Intervention/treatment |
|---|---|
| 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 |
- 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 ]
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.
- 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 ]
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 ]
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 ]
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 ]
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 ]
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.
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461369
Show 40 study locations
| 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 |
| Responsible Party: | Iroko Pharmaceuticals, LLC |
| ClinicalTrials.gov Identifier: | NCT01461369 |
| Other Study ID Numbers: |
DIC3-08-05 |
| First Posted: | October 28, 2011 Key Record Dates |
| Results First Posted: | May 26, 2014 |
| Last Update Posted: | May 26, 2014 |
| Last Verified: | April 2014 |
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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 Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |