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NCT00846209 · ClinicalTrials.gov registry record · Phase 4
Improving Prescription Drug Warning Labels
A Phase 4 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 4
- Development phase
- 500
- Enrollment target
NCT00846209 is a Phase 4 study that has completed, run by Northwestern University. The registered enrollment target is 500 participants.
The verdict
NCT00846209, a Phase 4 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 500 participants
- Enrollment target
Study Summary
Prior studies have documented a high prevalence of patients misunderstanding prescription drug warning labels, placing them at risk for medication error. We sought to evaluate the effectiveness of 'enhanced print' drug warnings to improve patient comprehension beyond a current standard.A three-arm, controlled clinical trial was conducted. Patients were assigned to receive 1) current standard drug warning labels on prescription containers (standard), 2) 'enhanced' drug warnings with text rewritten in plain language (enhanced text), or 3) enhanced language and icons developed with patient feedback (enhanced text + icon). Setting: Two academic and two community health primary care clinics in Chicago, IL and Shreveport, LA. Patients: 500 adult patients consecutively recruited at each clinic. Main Outcome Measure: Rates of correct interpretation of nine drug warning labels as determined by a blinded panel review of patients' verbatim responses.
Interventions
- OTHER Enhanced drug labeling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2007-06 |
| Est. Completion | 2009-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00846209
The ClinicalTrials.gov registry entry for NCT00846209 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Enhanced drug labeling is the first listed.
NCT00846209 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00846209 about?
NCT00846209 is a clinical study titled "Improving Prescription Drug Warning Labels". Prior studies have documented a high prevalence of patients misunderstanding prescription drug warning labels, placing them at risk for medication error. We sought to evaluate the effectiveness of 'enhanced print' drug warnings to improve patient comprehension beyond a current standard.A three-arm,...
What is the current status of trial NCT00846209?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 500 participants. The study started on 2007-06. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00846209?
The interventions under investigation include: Enhanced drug labeling (OTHER).
Who is sponsoring clinical trial NCT00846209?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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