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Also known as Polidocanol injectable foam (PEM), Polidocanol injectable foam
polidocanol injectable foam, 0.125% · 2 trials · 1 indication
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 subset of 5 VEINESQOL/ Sym items that have been determined in earlier studies to be most important to patients (heaviness, achiness, swelling, throbbing, and itching). The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25, with the lower end of the range being an indicator of less symptom intensity, and the higher end being an indicator of higher intensity). At Visit 2/baseline, Week 8, scores were calculated
| Arm | Type | Description |
|---|---|---|
| Polidocanol injectable foam 0.125% | EXPERIMENTAL | Polidocanol injectable foam 0.125% |
| Polidocanol injectable foam 0.5% | EXPERIMENTAL | Polidocanol injectable foam 0.5% |
| Polidocanol injectable foam 1.0% | EXPERIMENTAL | Polidocanol injectable foam 1.0% |
| Polidocanol injectable foam 2.0% | EXPERIMENTAL | Polidocanol injectable foam 2.0% |
| Vehicle | PLACEBO_COMPARATOR | Injection of vehicle comparator |
| polidocanol injectable foam, 0.125% | EXPERIMENTAL | - |
| polidocanol injectable foam, 0.5% | EXPERIMENTAL | - |
| polidocanol injectable foam, 1.0% | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Polidocanol injectable foam (PEM) | DRUG | Injection of Polidocanol injectable foam |
| Placebo Vehicle | DRUG | Placebo vehicle |
| polidocanol injectable foam, 0.125% | DRUG | active placebo for blinding |
| polidocanol injectable foam, 0.5% | DRUG | 0.5% polidocanol foam injection |
| polidocanol injectable foam, 1.0% | DRUG | 1.0% polidocanol foam injection |
| Vehicle | DRUG | injection of vehicle comparator |
Inclusion Criteria: * Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein * Ability to comprehend and sign an informed consent document and complete study questionnaires in English * Ability to record symptoms in accordance with the protocol * Symptomatic varic...
Polidocanol injectable foam, 0.125% is used to treat varicose veins, specifically for saphenofemoral junction incompetence. It is a sclerosing agent given as an injectable foam that targets the affected vein. The product is being developed by Boston Scientific Corporation as a minimally invasive treatment option for this cardiovascular condition.
Polidocanol injectable foam, 0.125% is developed by Boston Scientific Corporation, which trades under the ticker BSX. Boston Scientific is the sponsor responsible for the clinical development of this injectable foam formulation for varicose veins.
Polidocanol injectable foam, 0.125% is in Phase 3 clinical development. It has completed two Phase 3 trials and is not yet approved. The program remains investigational, with both trials completed and no active trials currently listed.
Polidocanol injectable foam, 0.125% has been studied in two completed Phase 3 trials: NCT01231373, which compared the foam to vehicle for saphenofemoral junction incompetence, and NCT01072877, an efficacy and safety study in the same condition. Both enrolled adults in the United States, with 235 and 279 participants respectively.
Yes, polidocanol injectable foam, 0.125% is also known as polidocanol injectable foam (PEM) or simply polidocanol injectable foam. PEM is an abbreviation for polidocanol endovenous microfoam, the same product candidate being developed by Boston Scientific for varicose veins.