Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine if LiRIS®, an investigational drug-delivery system, is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is inserted into the bladder via cystoscopy , remains in the bladder for 14 days, and is removed via cystoscopy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Collaborator: TARIS Biomedical, Inc.
• Treatments: Lidocaine

Criteria

Inclusion Criteria:

• Women age 18 and over

• Diagnosed with Interstitial Cystitis as defined by protocol

• Able and willing to complete questionnaires and diary

• Able to comply with visit schedule including Day 14 Removal visit

• Completion of blinded study prior to enrolling in unblinded part of study

Exclusion Criteria:

• Pregnant or lactating women

• Bladder or urethra anatomical feature that would prevent the safe indwelling or insertion of the investigational product

• History or presence of any condition that would make it difficult to evaluate symptoms

• Did not complete blinded study (unblinded part of study only)