Safety, Tolerability and Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purposes of the study is to determine if LiRIS®, an investigational drug-delivery system, is safe and tolerable in women with Interstitial Cystitis (IC), and to evaluate any change in IC symptoms following LiRIS administration.

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

Details

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

Criteria

Inclusion Criteria

Blinded study:

• Women age 18 and over

• Diagnosed with Interstitial Cystitis as defined by protocol

• Able to report IC symptoms of bladder pain, voiding habits, as required by protocol, and record in diary

• Able to comply with visit schedule and diary completion at home

Open-label Extension:

• Must have completed the blinded study prior to screening for the Open-label extension

Exclusion Criteria (Blinded and Open-Label Extension):

• Pregnant or lactating women

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

• Bladder or urethral abnormality that would prevent safe insertion of investigational product

• Requiring medication not allowed per study protocol