Actual Use and Compliance Study Of Ibuprofen 600 Mg Immediate Release/Extended Release Tablets In At-Risk OTC Consumers
Public ClinicalTrials.gov record NCT03722238. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
MULTICENTER ACTUAL USE AND COMPLIANCE STUDY OF IBUPROFEN 600 MG IMMEDIATE RELEASE/EXTENDED RELEASE TABLETS AMONG TARGETED (AT-RISK) CONSUMERS IN A SIMULATED OVER-THE-COUNTER ENVIRONMENT
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03722238
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 613 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 27, 2018 (Actual)
- Primary completion
- Oct 28, 2019 (Actual)
- Completion
- Oct 28, 2019 (Actual)
- Last update posted
- Sep 24, 2021
2018 – 2019
United States locations
- U.S. sites
- 27
- U.S. states
- 16
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mills Pharmacy at Bluff Park | Hoover | Alabama | 35226 | — |
| Community Clinical Pharmacy | Mesa | Arizona | 85202 | — |
| ACACIA Apothecary and Wellness | Tucson | Arizona | 85704 | — |
| Coconut Grove Pharmacy | Miami | Florida | 33133 | — |
| Summerfield Pharmacy | Riverview | Florida | 33578 | — |
| Huff's Drug Store | Ellijay | Georgia | 30540 | — |
| Family Care Pharmacy | Highland | Illinois | 62249 | — |
| Rice's Pharmacy | Beaver Dam | Kentucky | 42320 | — |
| Catonsville Pharmacy | Catonsville | Maryland | 21228 | — |
| Goodrich Pharmacy | Anoka | Minnesota | 55303 | — |
| Kemper Corner Drug | Elk River | Minnesota | 55330 | — |
| Cub Pharmacy #744 | Rosemount | Minnesota | 55068 | — |
| The Medicine Shoppe and Elsberry Pharmacy | Elsberry | Missouri | 63343 | — |
| Albers Medical Pharmacy | Kansas City | Missouri | 64111 | — |
| Countryside Pharmacy | Savannah | Missouri | 64485 | — |
| Texas Road Pharmacy | Monroe | New Jersey | 08831 | — |
| Dakota Pharmacy of Bismarck | Bismarck | North Dakota | 58501 | — |
| Family Prescription Center | Bethlehem | Pennsylvania | 18015 | — |
| RxXPress Health Mart Pharmacy | Grove City | Pennsylvania | 16127 | — |
| Medical Center Compounding Pharmacy & Health Center | Cleveland | Tennessee | 37311 | — |
| Buckeye Drugs | Lebanon | Tennessee | 37087 | — |
| Summerwood Pharmacy and Compounding | Houston | Texas | 77044 | — |
| The Medicine Shoppe #708 | Sherman | Texas | 75092 | — |
| BrickStreet Pharmacy | Tyler | Texas | 75701 | — |
| Bountiful Drug | Bountiful | Utah | 84010 | — |
| The Medicine Center | Salt Lake City | Utah | 84121 | — |
| Montpelier Pharmacy, Inc. | Montpelier | Virginia | 23192 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03722238, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 24, 2021 · Synced Nov 6, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03722238 live on ClinicalTrials.gov.