Phase 3
Completed N=602
Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain
Source: ClinicalTrials.gov NCT01510912 ↗Enrolled (actual)
602
Serious AEs
7.0%
Results posted
May 2014
Primary outcomePrimary: Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination — 451; 41; 42 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination |
451; 41; 42 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01510912). 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. Informational only — not medical advice.