CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 59 enrolled
Drug / intervention
LiRIS® +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.

Search/NCT02395042
NCT02395042Phase 2Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Placebo-controlled Study, Evaluating Safety and Efficacy of LiRIS® 400 mg in Females With Interstitial Cystitis With Hunner's Lesions

Allergan·interventional·Posted Mar 20, 2015·Updated Oct 5, 2018

In Brief

A Phase 2 clinical trial evaluating LiRIS® and LiRIS Placebo for Cystitis, Interstitial and Ulcer. Completed, enrolled 59 participants across 19 sites in 2 countries.

Detailed Summary

This is a safety and efficacy study of LiRIS® in females with interstitial cystitis with Hunner's lesions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystitis, Interstitial, Ulcer
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 20, 2015
Enrollment StartApr 15, 2015
Primary CompletionJun 29, 2017
Study CompletionNov 20, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.3 years ago

Interventions

LiRIS®drug

LiRIS® is a drug-device combination product which is placed in the bladder during cystoscopy and remains in the bladder, gradually releasing lidocaine until removed from the bladder via cystoscopy.

LiRIS Placebodrug

LiRIS placebo is a drug-device combination product, matching the LiRIS® which is placed in the bladder during cystoscopy, remains in the bladder until removed from the bladder via cystoscopy