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NCT01231373 · ClinicalTrials.gov registry record · Phase 3
Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
A Phase 3 study of Varicose Veins, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 235
- Enrollment target
- 12
- Study locations
NCT01231373: Completed Phase 3 study of Varicose Veins, sponsored by Boston Scientific Corporation.
NCT01231373 is a Phase 3 study of Varicose Veins that has completed, run by Boston Scientific Corporation. The registered enrollment target is 235 participants, above the 131-participant average among 6 other Varicose Veins trials with a reported enrollment target (79% higher). The trial reports 12 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01231373, a Phase 3 study of Varicose Veins, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 235 participants
- Enrollment target
- 12
- Study locations
Study Summary
Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the safety and effectiveness of three different concentrations of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.
Primary Outcome
The 9 varicose vein symptoms were to be assessed and graded on a 6-point (i.e., 0-5) duration scale and an 11-point (i.e., 0-10) intensity scale, and the patient's level activity for that day was to be assessed and graded on the 6-point (i.e., 0-5) duration scale. The 9 varicose vein symptoms assessed using the e-diary were derived from the first question of the modified Venous Insufficiency Epidemiologic and Economic Study-Quality of Life/Symptoms (VEINES-QOL/Sym) instrument. The VVSymQ is a su
Conditions Studied
Interventions
- DRUG Vehicle
- DRUG polidocanol injectable foam, 0.125%
- DRUG polidocanol injectable foam, 0.5%
- DRUG polidocanol injectable foam, 1.0%
Study Locations (12)
California
- - San Diego
- - San Diego
Maryland
- - Frederick
- - Hunt Valley
Pennsylvania
- - Monroeville
- - Pittsburgh
Alabama
- - Dothan
Indiana
- - Lafayette
New Mexico
- - Los Alamos
Oklahoma
- - Oklahoma City
South Carolina
- - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2010-11 |
| Est. Completion | 2014-08 |
| Phase | Phase 3 |
What the finished NCT01231373 record still lists
NCT01231373 is an interventional study that assigns participants to a tested intervention. The registered 235 participants enrollment target is mid-sized for trials with a published cap, above the 131-participant average among 6 other Varicose Veins trials with a reported enrollment target (79% higher).
The record links to 1 condition, with Varicose Veins appearing as the primary indexed condition, and to 4 interventions - of which Vehicle is the first listed.
NCT01231373 lists 12 locations in 9 states (California, Maryland, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT01231373 about?
NCT01231373 is a clinical study titled "Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence". Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the safety and effectiveness of three different concentra...
What is the current status of trial NCT01231373?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 235 participants. The study started on 2010-11. Estimated completion is 2014-08.
What conditions does trial NCT01231373 study?
This clinical trial studies the following conditions: Varicose Veins.
What interventions are being tested in trial NCT01231373?
The interventions under investigation include: Vehicle (DRUG), polidocanol injectable foam, 0.125% (DRUG), polidocanol injectable foam, 0.5% (DRUG), polidocanol injectable foam, 1.0% (DRUG).
Who is sponsoring clinical trial NCT01231373?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01231373 being conducted?
This trial has 12 study locations across Alabama, California, Indiana, Maryland, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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