NCT02395042

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Allergan · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Cystitis, Interstitial
• Ulcer

Interventions

Type	Name	Description
DRUG	LiRIS®	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.
DRUG	LiRIS Placebo	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

Timeline

• Start date: 2015-04-15
• Primary completion: 2017-06-29
• Completion: 2017-11-20
• First posted: 2015-03-20
• Last updated: 2018-10-05
• Results posted: 2018-10-05

Locations

19 sites across 2 countries: United States, Canada