drugset

drugset / Trial / NCT02395042

A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's Lesions

NCT02395042 ↗

Phase 2 Completed 59 enrolled Allergan

RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start: 2015-04-15
Primary completion: 2017-06-29
Completion: 2017-11-20

Outcome

Missed primary endpoint

paper There was no statistically significant difference in the primary endpoint PMID 34288094 ↗

registry p = 0.142 NCT02395042 ↗

Publications

Evans R, Kohan A, Moldwin R, Radecki D, Geib T, Peters KM. Safety, tolerability, and efficacy of LiRIS 400 mg in women with interstitial cystitis/bladder pain syndrome with or without Hunner lesions. Neurourol Urodyn. 2021 Sep;40(7):1730-1739. doi: 10.1002/nau.24702. Epub 2021 Jul 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lidocaine	Other / unclassified	400 mg	Other

Indications