Trial · NCT02335242
Sildenafil for the Treatment of Lymphatic Malformations
NCT02335242, Phase 2, Completed, Stanford University; results first posted 2022-11-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sildenafil for the Treatment of Lymphatic Malformations. Trials, record NCT02335242. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02335242
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sildenafil for the Treatment of Lymphatic Malformations
- NCT number
- NCT02335242
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Lymphatic Malformations, Lymphatic Diseases
- Interventions
- Sildenafil 20 mg tablets, Placebo tablets (resembling Revatio)
- First posted
- 2015-01-09
- Last updated
- 2022-11-17
- Results first posted
- 2022-11-17
- Limitations and caveats
- Only 1 of 4 planned sites participated in this trial; the study did not meet its planned enrollment and the results are underpowered.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Lesion Volume of the Test Medication as Evaluated by MRI Examination. | Baseline, week 20 | Participants will be followed for the duration of the study, an expected average of 20 weeks. |
| Secondary | Change in Subject's Assessment of Change in Lymphatic Malformation Overall Score | Baseline, week 20 | Subject's evaluation of the overall change in lymphatic malformation. Participants will be followed from baseline to 20 weeks. Patients rated change as no improvement, minimal improvement (1-25% change), fair improvement (25-50% change), good improvement (50-75% change), and excellent improvement (75-100% change). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Lesion Volume of the Test Medication as Evaluated by MRI Examination. | Baseline, week 20 | Participants who completed each treatment period are included in the analysis | percentage of volume | MEAN |
| SECONDARY | Change in Subject's Assessment of Change in Lymphatic Malformation Overall Score | Baseline, week 20 | Participants with data at both baseline and week 20 are included in the analysis | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Lesion Volume of the Test Medication as Evaluated by MRI Examination. | Double-Blind Placebo | 5.89 | Standard Deviation 13.5 | percentage of volume | |
| Change in Lesion Volume of the Test Medication as Evaluated by MRI Examination. | Open-Label Sildenafil | -8.54 | Standard Deviation 12.1 | percentage of volume | |
| Change in Lesion Volume of the Test Medication as Evaluated by MRI Examination. | Double-blind Sildenafil | -0.642 | Standard Deviation 18.3 | percentage of volume | |
| Change in Subject's Assessment of Change in Lymphatic Malformation Overall Score | Double-Blind Placebo | No improvement | 1 | Participants | |
| Change in Subject's Assessment of Change in Lymphatic Malformation Overall Score | Double-Blind Sildenafil | No improvement | 2 | Participants | |
| Change in Subject's Assessment of Change in Lymphatic Malformation Overall Score | Double-Blind Placebo | Minimal improvement | 2 | Participants | |
| Change in Subject's Assessment of Change in Lymphatic Malformation Overall Score | Double-Blind Sildenafil | Minimal improvement | 4 | Participants | |
| Change in Subject's Assessment of Change in Lymphatic Malformation Overall Score | Double-Blind Placebo | Fair improvement | 0 | Participants | |
| Change in Subject's Assessment of Change in Lymphatic Malformation Overall Score | Double-Blind Sildenafil | Fair improvement | 1 | Participants | |
| Change in Subject's Assessment of Change in Lymphatic Malformation Overall Score | Double-Blind Placebo | Good improvement | 2 | Participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized Phase (20 Weeks) | STARTED | Double-Blind Placebo Then Open-Label Sildenafil | 8 | |
| Randomized Phase (20 Weeks) | STARTED | Double-Blind Sildenafil | 11 | |
| Randomized Phase (20 Weeks) | COMPLETED | Double-Blind Placebo Then Open-Label Sildenafil | 7 | |
| Randomized Phase (20 Weeks) | COMPLETED | Double-Blind Sildenafil | 11 | |
| Randomized Phase (20 Weeks) | NOT COMPLETED | Double-Blind Placebo Then Open-Label Sildenafil | 1 | |
| Randomized Phase (20 Weeks) | NOT COMPLETED | Double-Blind Sildenafil | 0 | |
| Open-label Phase (20 Weeks) | STARTED | Double-Blind Placebo Then Open-Label Sildenafil | 6 | |
| Open-label Phase (20 Weeks) | STARTED | Double-Blind Sildenafil | 0 | |
| Open-label Phase (20 Weeks) | COMPLETED | Double-Blind Placebo Then Open-Label Sildenafil | 6 | |
| Open-label Phase (20 Weeks) | COMPLETED | Double-Blind Sildenafil | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events39
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 | Cold | Respiratory, thoracic and mediastinal disorders | Double-Blind Placebo | 7 | 8 | |
| other | Cold | Respiratory, thoracic and mediastinal disorders | Open-Label Sildenafil | 2 | 6 | |
| other | Cold | Respiratory, thoracic and mediastinal disorders | Double-Blind Sildenafil | 6 | 10 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Double-Blind Placebo | 1 | 8 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Open-Label Sildenafil | 2 | 6 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Double-Blind Sildenafil | 3 | 10 | |
| other | Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Double-Blind Placebo | 1 | 8 | |
| other | Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Open-Label Sildenafil | 2 | 6 | |
| other | Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Double-Blind Sildenafil | 1 | 10 | |
| other | Abdominal pain/bloating | Gastrointestinal disorders | Double-Blind Placebo | 0 | 8 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double-Blind Placebo | 0 | 8 |
| Total, all-cause mortality | Open-Label Sildenafil | 0 | 6 |
| Total, all-cause mortality | Double-Blind Sildenafil | 0 | 10 |
| Total, other adverse events | Double-Blind Placebo | 8 | 8 |
| Total, other adverse events | Open-Label Sildenafil | 5 | 6 |
| Total, other adverse events | Double-Blind Sildenafil | 10 | 10 |
| Total, serious adverse events | Double-Blind Placebo | 0 | 8 |
| Total, serious adverse events | Open-Label Sildenafil | 0 | 6 |
| Total, serious adverse events | Double-Blind Sildenafil | 0 | 10 |
Source ClinicalTrials.gov
Papers19
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01FD004372 | Phase 2 Study of Sildenafil for the Treatment of Lymphatic Malformations | TENG, JOYCE MING CAO; BRUCKNER, ANNA LEE; MANCINI, ANTHONY J | STANFORD UNIVERSITY | FOOD AND DRUG ADMINISTRATION | 2014 to 2019 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02335242
GET https://conductscience.org/api/trials/v1/NCT02335242/events?page=2