Overview

This trial is active, not recruiting.

Conditions cystitis, interstitial, painful bladder syndrome
Treatments liris®, liris placebo
Phase phase 2
Sponsor Allergan
Start date May 2015
End date November 2016
Trial size 116 participants
Trial identifier NCT02411110, 201025-002

Summary

This is a safety and efficacy study of LiRIS® in females with interstitial cystitis/bladder pain syndrome.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Treatment period 1: continuous release of lidocaine inserted into the bladder by cystoscopy. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy.
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.
(Other)
Treatment period 1: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy. Treatment Period 2: optional of continuous release of lidocaine inserted into the bladder by cystoscopy.
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.
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.

Primary Outcomes

Measure
Average Daily Bladder Pain on an 11-Point Scale
time frame: Week 4

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Diagnosis of interstitial cystitis or bladder pain syndrome Exclusion Criteria: - Diagnosis of interstitial cystitis with Hunner's lesions/ulcers - Previous treatment with LiRIS®

Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Allergan.