MedTrace Logo

Sildenafil for the Treatment of Lymphatic Malformations

NCT02335242 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-11-17

Study results available
· View outcomes & findings →

Summary

A Phase 2 study to evaluate safety and efficacy of sildenafil taken orally to improve or resolve lymphatic malformations in children. Subjects may receive either placebo or treatment in an oral dosage with an open label extension for subjects who received placebo. The study treatment assignment will be randomized in a double blind fashion. MRI examination will evaluate change in lesion volume due to treatment. Other safety and efficacy measures will be taken through the 32-week study duration.

Funding Source - FDA OOPD

Conditions

  • Lymphatic Malformations
  • Lymphatic Diseases

Interventions

DRUG

Sildenafil 20 mg tablets

OTHER

Placebo tablets (resembling Revatio)

Sponsors & Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago

    collaborator OTHER

  • Stanford University

    lead OTHER

Principal Investigators

  • Joyce Teng, MD, PhD · Stanford School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-23
Primary Completion
2021-03-30
Completion
2021-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02335242 on ClinicalTrials.gov