This is an open label, multicenter, 30 day study designed to mimic an OTC like environment in which subjects will use the product after making a purchase decision about ibuprofen 400 mg caplets based only on their reading of the Drug Facts Label (DFL) and other information on the package.
- Male or female at least 18 years of age (19 years of age in Alabama)
- Subject reports taking over-the-counter (OTC) analgesics for pain or fever relief
- Current government-issued identification (ID)
- Pregnant or breastfeeding females
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Actual Use Trial of Ibuprofen 400 mg | |||
| Official Title ICMJE | A Multicenter Actual Use And Compliance Study Of Ibuprofen 400 Mg In A Simulated Over-the-counter Environment | |||
| Brief Summary | This is an open label, multicenter, 30 day study designed to mimic an OTC like environment in which subjects will use the product after making a purchase decision about ibuprofen 400 mg caplets based only on their reading of the Drug Facts Label (DFL) and other information on the package. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Masking: None (Open Label) | |||
| Condition ICMJE | Patient Compliance | |||
| Intervention ICMJE | Drug: Ibuprofen 400 mg caplet 400 milligram (mg) caplet according to Drug Facts label | |||
| Study Arms ICMJE | Experimental: Ibuprofen caplet arm Intervention: Drug: Ibuprofen 400 mg caplet | |||
| Publications * | Not Provided | |||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 738 | |||
| Original Estimated Enrollment ICMJE | 730 | |||
| Actual Study Completion Date ICMJE | May 2015 | |||
| Actual Primary Completion Date | May 2015 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT02294019 | |||
| Other Study ID Numbers ICMJE | B3491013 AUT ( Other Identifier: Alias Study Number ) | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | April 2016 | |||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
