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NCT00449982 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Polyphenon E to Treat External Genital Warts
A Phase 3 study of Condylomata Acuminata, sponsored by MediGene.
- Completed
- Registry status
- Phase 3
- Development phase
- 480
- Enrollment target
- 12
- Study locations
NCT00449982 is a Phase 3 study of Condylomata Acuminata that has completed, run by MediGene. The registered enrollment target is 480 participants, above the 21-participant average among 3 other Condylomata Acuminata trials with a reported enrollment target (2186% higher). The trial reports 12 study locations across 7 states.
The verdict
NCT00449982, a Phase 3 study of Condylomata Acuminata, has completed, sponsored by MediGene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 480 participants
- Enrollment target
- 12
- Study locations
Study Summary
The purpose of this study is to investigate the clinical efficacy, safety and tolerability of a Polyphenon E Ointment 10% and a Polyphenon E Ointment 15% in the treatment of external genitial warts in male and female patients.
Conditions Studied
Interventions
- DRUG Polyphenon E Ointment 10%, Polyphenon E Ointment 15%
Study Locations (12)
Other
- - Buenos Aires
- - Santiago, Temuco
- - Colombia, Bogota, Medellin, Risaralda
- - Cuautitlan, Mexico, Guadalajara, Durango, Ciliacan, Puebla
- - Lima, Calao
- - Bucaresti, Brasov, Iasi, Cluj-Napoca
California
- - Davis, San Diego
Colorado
- - Denver
New York
- - New York
Oregon
- - Portland
Texas
- - Houston, Dallas, Austin
Vermont
- - Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 480 participants |
| Start Date | 2003-07 |
| Est. Completion | 2004-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00449982
The ClinicalTrials.gov registry entry for NCT00449982 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 480 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 21-participant average among 3 other Condylomata Acuminata trials with a reported enrollment target (2186% higher). The listed sponsor is MediGene, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Condylomata Acuminata appearing as the primary indexed condition, and to 1 intervention - of which Polyphenon E Ointment 10%, Polyphenon E Ointment 15% is the first listed.
NCT00449982 reports 12 study locations spanning 7 distinct geographic areas - top geographies include Other, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT00449982 about?
NCT00449982 is a clinical study titled "Efficacy and Safety Study of Polyphenon E to Treat External Genital Warts". The purpose of this study is to investigate the clinical efficacy, safety and tolerability of a Polyphenon E Ointment 10% and a Polyphenon E Ointment 15% in the treatment of external genitial warts in male and female patients.
What is the current status of trial NCT00449982?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 480 participants. The study started on 2003-07. Estimated completion is 2004-08.
What conditions does trial NCT00449982 study?
This clinical trial studies the following conditions: Condylomata Acuminata.
What interventions are being tested in trial NCT00449982?
The interventions under investigation include: Polyphenon E Ointment 10%, Polyphenon E Ointment 15% (DRUG).
Who is sponsoring clinical trial NCT00449982?
This trial is sponsored by MediGene, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00449982 being conducted?
This trial has 12 study locations across California, Colorado, New York, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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