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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
305
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.
Time frame: Baseline to Week 12/Early Termination
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.
Time frame: 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.
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Premier Research Group - Phoenix
Phoenix, Arizona, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Acri-Phase I, LLC
Anaheim, California, United States
Med Center
Carmichael, California, United States
Expresscare Clinical Research
Colorado Springs, Colorado, United States
Westside Center for Clinical Research
Jacksonville, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Well Pharma Medical Research, Corporation
Miami, Florida, United States
Peninsula Research, Inc
Ormond Beach, Florida, United States
Alliance Clinical Research
Winter Park, Florida, United States
...and 30 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 12/Early Termination