Trial · NCT01428076
Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM)
NCT01428076, Phase 1, Completed, Boston Scientific Corporation; results first posted 2014-03-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM). Trials, record NCT01428076. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01428076
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM)
- NCT number
- NCT01428076
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 21 participants, actual
- Lead sponsor
- Boston Scientific Corporation
- Conditions
- Varicose Veins
- Interventions
- Polidocanol Endovenous Microfoam (PEM)
- First posted
- 2011-09-02
- Last updated
- 2021-04-21
- Results first posted
- 2014-03-31
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Weight-adjusted Polidocanol Cmax (Serum) | pharmacokinetics measured- predose, 1, 4, 5, 7, 9, 11, 14, 15, 17, 20, 25, 30 minutes post dose, 1, 2, 3, 4, 5, 6, 8 hours post dose | Cmax measured and adjusted for weight |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Weight-adjusted Polidocanol Cmax (Serum) | pharmacokinetics measured- predose, 1, 4, 5, 7, 9, 11, 14, 15, 17, 20, 25, 30 minutes post dose, 1, 2, 3, 4, 5, 6, 8 hours post dose | PK population | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Weight-adjusted Polidocanol Cmax (Serum) | Males-polidocanol 1% | 584.1 | Standard Deviation 142.8 | ng/mL | |
| Weight-adjusted Polidocanol Cmax (Serum) | Males-polidocanol 2% | 1188.7 | Standard Deviation 341.7 | ng/mL | |
| Weight-adjusted Polidocanol Cmax (Serum) | Females-polidocanol 1% | 840.7 | Standard Deviation 437.6 | ng/mL | |
| Weight-adjusted Polidocanol Cmax (Serum) | Females- Polidocanol 2% | 1189.6 | Standard Deviation 331.2 | ng/mL |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Polidocanol 1% | 9 | |
| Overall Study | STARTED | Polidocanol 2% | 12 | |
| Overall Study | COMPLETED | Polidocanol 1% | 9 | |
| Overall Study | COMPLETED | Polidocanol 2% | 11 | |
| Overall Study | NOT COMPLETED | Polidocanol 1% | 0 | |
| Overall Study | NOT COMPLETED | Polidocanol 2% | 1 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain upper | Gastrointestinal disorders | Polidocanol 1% | 1 | 9 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Polidocanol 2% | 0 | 12 | 0 |
| other | Extravasation | General disorders | Polidocanol 1% | 1 | 9 | 1 |
| other | Extravasation | General disorders | Polidocanol 2% | 0 | 12 | 0 |
| other | Respiratory tract infection | Infections and infestations | Polidocanol 1% | 1 | 9 | 1 |
| other | Respiratory tract infection | Infections and infestations | Polidocanol 2% | 0 | 12 | 0 |
| other | Facial bones fracture | Injury, poisoning and procedural complications | Polidocanol 1% | 0 | 9 | 0 |
| other | Facial bones fracture | Injury, poisoning and procedural complications | Polidocanol 2% | 1 | 12 | 1 |
| other | muscle spasm | Musculoskeletal and connective tissue disorders | Polidocanol 1% | 1 | 9 | 1 |
| other | muscle spasm | Musculoskeletal and connective tissue disorders | Polidocanol 2% | 0 | 12 | 0 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Polidocanol 1% | ||
| Total, all-cause mortality | Polidocanol 2% | ||
| Total, other adverse events | Polidocanol 1% | 4 | 9 |
| Total, other adverse events | Polidocanol 2% | 5 | 12 |
| Total, serious adverse events | Polidocanol 1% | 0 | 9 |
| Total, serious adverse events | Polidocanol 2% | 0 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Polidocanol 1% vs Polidocanol 2%: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01428076
GET https://conductscience.org/api/trials/v1/NCT01428076/events?page=2