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NCT00948428 · ClinicalTrials.gov registry record · Phase 3
Bioequivalence of Generic Imiquimod Cream, 5% When Compared to Aldara™ (Imiquimod) Cream, 5% in the Treatment of Actinic Keratosis
A Phase 3 study, sponsored by Actavis.
- Completed
- Registry status
- Phase 3
- Development phase
- 462
- Enrollment target
NCT00948428 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 462 participants.
The verdict
NCT00948428, a Phase 3 study, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 462 participants
- Enrollment target
Study Summary
At the end of the study, safety and efficacy outcome measures will be compared to determine a) if dosing with Generic Imiquimod cream, 5% is therapeutically equivalent to the currently marketed Aldara (imiquimod) cream, 5% and b) if both imiquimod 5% creams are superior in comparison to the Vehicle cream.
Interventions
- DRUG Vehicle Cream
- DRUG imiquimod
- DRUG Aldara™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 462 participants |
| Start Date | 2008-05 |
| Est. Completion | 2009-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00948428
The ClinicalTrials.gov registry entry for NCT00948428 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 462 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actavis, which has 79 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Vehicle Cream is the first listed.
NCT00948428 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00948428 about?
NCT00948428 is a clinical study titled "Bioequivalence of Generic Imiquimod Cream, 5% When Compared to Aldara™ (Imiquimod) Cream, 5% in the Treatment of Actinic Keratosis". At the end of the study, safety and efficacy outcome measures will be compared to determine a) if dosing with Generic Imiquimod cream, 5% is therapeutically equivalent to the currently marketed Aldara (imiquimod) cream, 5% and b) if both imiquimod 5% creams are superior in comparison to the Vehicle ...
What is the current status of trial NCT00948428?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 462 participants. The study started on 2008-05. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00948428?
The interventions under investigation include: Vehicle Cream (DRUG), imiquimod (DRUG), Aldara™ (DRUG).
Who is sponsoring clinical trial NCT00948428?
This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.
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