Patient Compliance Clinical Trial
Official title:
A Multicenter Actual Use And Compliance Study Of Ibuprofen 400 Mg In A Simulated Over-the-counter Environment
| Verified date | June 2015 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 738 |
| Est. completion date | May 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Current government-issued identification (ID) - Pregnant or breastfeeding females |
Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| United States | Phil's Pills, Inc. | Albuquerque | New Mexico |
| United States | Goodrich Pharmacy | Andover | Minnesota |
| United States | Goodrich Pharmacy | Anoka | Minnesota |
| United States | Family Prescription Center | Bethlehem | Pennsylvania |
| United States | Goodrich Pharmacy | Blaine | Minnesota |
| United States | The Medicine Shoppe | Bountiful | Utah |
| United States | Kroger Pharmacy #342 | Cary | North Carolina |
| United States | Sutton Family Pharmacy | Dalton | Georgia |
| United States | Goodrich Pharmacy | Elk River | Minnesota |
| United States | Foothills Compounding Pharmacy | Enumclaw | Washington |
| United States | Garden Drug | Fort Lauderdale | Florida |
| United States | Wynn's Pharmacy Inc. | Griffin | Georgia |
| United States | Robert's Discount Pharmacy | Hoover | Alabama |
| United States | Albers' Specialty Pharmacy | Kansas City | Missouri |
| United States | Ostrom Drugs | Kenmore | Washington |
| United States | Northview Pharmacy | Layton | Utah |
| United States | Pharmacy at the Pig | McCalla | Alabama |
| United States | Community Clinical Pharmacy | Mesa | Arizona |
| United States | Texas Road Pharmacy | Monroe | New Jersey |
| United States | Pill Box Pharmacy and Medical Supply | Pembroke Pines | Florida |
| United States | Summerfield Pharmacy | Riverview | Florida |
| United States | Countryside Pharmacy | Savannah | Missouri |
| United States | Cub Pharmacy Number 1924 | St. Louis Park | Minnesota |
| United States | Total Health and Wellness Center of Taos | Taos | New Mexico |
| United States | Family Plaza Pharmacy | West Jordan | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of participants taking greater than 3 caplets on no more than 2 use days | 30 days | No | |
| Secondary | Percentage of participants taking greater than 1 caplet at a time | 30 days | No |
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