At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 54 enrolled
Drug / intervention
ubenimex +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Ubenimex in Adult Patients With Lymphedema of The Lower Limb: a Phase 2, RAndomized, Double-blind, Placebo-controlled Study of Efficacy, Safety, and Pharmacokinetics (ULTRA)
In Brief
A Phase 2 clinical trial evaluating ubenimex and placebo for Lymphedema. Completed, enrolled 54 participants across 4 sites in 2 countries.
Detailed Summary
This proof-of-concept study is designed as a randomized, double-blind, placebo-controlled study comparing ubenimex at 150 mg, 3 times daily (total daily dose of 450 mg) with placebo for 6 months treatment period in patients with leg lymphedema.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphedema
CountriesAustralia, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartJun 2016
Primary CompletionOct 2018
Study CompletionFeb 2019
TodayJul 2026
First PostedMar 7, 2016
Enrollment StartJun 1, 2016
Primary CompletionOct 1, 2018
Study CompletionFeb 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.3 years ago
Interventions
ubenimexdrug
placeboother