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NCT01072877 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
A Phase 3 study, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 279
- Enrollment target
NCT01072877: Completed Phase 3 study, sponsored by Boston Scientific Corporation.
NCT01072877 is a Phase 3 study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 279 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01072877, a Phase 3 study, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 279 participants
- Enrollment target
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 injectable foam 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 of 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
Interventions
- DRUG Polidocanol injectable foam (PEM)
- DRUG Placebo Vehicle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 279 participants |
| Start Date | 2010-12 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
What the finished NCT01072877 record still lists
NCT01072877 is an interventional study that assigns participants to a tested intervention. The registered 279 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Polidocanol injectable foam (PEM) is the first listed.
NCT01072877 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01072877 about?
NCT01072877 is a clinical study titled "Efficacy and Safety Study of Polidocanol Injectable Foam 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 NCT01072877?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 279 participants. The study started on 2010-12. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01072877?
The interventions under investigation include: Polidocanol injectable foam (PEM) (DRUG), Placebo Vehicle (DRUG).
Who is sponsoring clinical trial NCT01072877?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01072877's enrollment target sits among peer trials
279 1199th of 2000 higher than 801 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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