Phase 3
N=305
Study of Diclofenac Capsules to Treat Osteoarthritis Pain
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01461369 ↗Enrolled (actual)
305
Serious AEs
2.9%
Results posted
May 2014
Primary outcome: Primary: 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. — -39.04; -44.14; -32.46 mm — p=0.0024
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Diclofenac (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Iroko Pharmaceuticals, LLC
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
-39.04; -44.14; -32.46 | 0.0024 sig |
| SECONDARY 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. |
-31.40; -37.42; -21.60 | <0.0001 sig |
| SECONDARY 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. |
-36.64; -43.51; -31.08 | 0.0011 sig |
| SECONDARY 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. |
-35.62; -41.38; -28.14 | 0.0001 sig |
| SECONDARY 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. |
-30.25; -35.86; -23.22 | 0.0002 sig |
| SECONDARY 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. |
-36.41; -41.33; -30.95 | 0.0028 sig |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01461369). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.