At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 10 enrolled
Drug / intervention
LiRIS® 400 mgdrug
Likely dose
LiRIS® 400 mgfrom 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.
A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of LiRIS® 400 mg in Women With Ulcerative Interstitial Cystitis
In Brief
A Phase 1 clinical trial evaluating LiRIS® 400 mg for Chronic Interstitial Cystitis. Completed, enrolled 10 participants across 2 sites.
Detailed Summary
The purpose of the study is to evaluate if LiRIS 400 mg is safe and tolerable when administered to women with Interstitial Cystitis with Hunner's lesions, and to evaluate any change in the bladder or in IC symptoms, following LiRIS administration.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Interstitial Cystitis
CountriesUnited States
CollaboratorsTARIS Biomedical, Inc.
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 2013
Enrollment StartJul 2013
Primary CompletionMay 2014
Study CompletionJun 2014
TodayJul 2026
First PostedJun 18, 2013
Enrollment StartJul 1, 2013
Primary CompletionMay 1, 2014
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.0 years ago
Interventions
LiRIS® 400 mgdrug
LiRIS® 400 mg is a drug-device combination product which is placed in the bladder during cystoscopy, remains in the bladder for up to 14 days gradually releasing lidocaine, and removed from the bladder via cystoscopy.