Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT01510912
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01510912
Study Brief:
Protocol Section:
NCT01510912