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An Open Label, Actual Use Study in Consumers Taking an Extended-Release Over the Counter NSAID in a Naturalistic Setting
The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.
Details
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 497 |
| Start date | 2008-07 |
| Completion | 2008-11 |
Conditions
- Pain
Interventions
- Naproxen Sodium ER (BAYH6689)
Primary outcomes
- Use Days With One or More Misuse Occasions — 1 month
Misuse occasion: any reported use of 2 or more tablets within a 22 hour period (included use of 2 tablets in 1 dose or the use of 1 tablet at one time and 1+ tablets at a later time within the same 22 hour period). Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in 1 use-day. If a subject reported product consumption on 3 different days this resulted in 3 use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data.
Countries
United States