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:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT02287350
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects between 2-12 years of age.
* Subjects must be post-op, having mild or moderate acute pain.
Other inclusions apply.
Exclusion Criteria:
* Subject has a known history of allergic reaction, hypersensitivity to diclofenac, aspirin, acetaminophen, or reaction to the non-active ingredients of the study medication.
* Subject has been taking analgesics for 48-72 hours prior to Screening.
* Subject has a history of any GI event greater than 6 months before Screening.
* Subject is currently receiving any medication that is contraindicated for use concomitantly with diclofenac or acetaminophen.
* Subject is requiring treatment for pre-existing hypertension.
Other exclusions apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
12 Years
Study:
NCT02287350
Study Brief:
Protocol Section:
NCT02287350