Actual Use and Compliance Study Of Ibuprofen 600 Mg Immediate Release/Extended Release Tablets In At-Risk OTC Consumers
Status:
Terminated
Trial end date:
2019-10-28
Target enrollment:
Participant gender:
Summary
This will be an open-label, multicenter, 30-day, unsupervised AUS among targeted (at-risk)
adult and adolescent consumers designed to mimic an OTC-like environment. More specifically,
"at-risk" consumers, as discussed with the FDA, will comprise elderly consumers (>65 years of
age), consumers with an increased risk of gastrointestinal (GI) bleeding or cardiovascular
(CV) adverse events, consumers who experience severe pain, low literacy subjects, and
adolescents (12-17 years of age). The total number of subjects expected to enroll into the
study is approximately 820. Sites will be pharmacies in diverse geographic locations around
the US. Prospective adult subjects will be recruited via general population and targeted risk
condition advertising (although participants will not be informed as to specific health
conditions for which they are being recruited), while adolescents will be recruited using
targeted, outbound pre-recruiting telephone calls. Subjects (or the parents/guardians of
prospective adolescent subjects) responding to the advertisements or recruitment calls will
be initially screened by telephone, and eligibility will subsequently be verified in-person
at the pharmacy site.