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

A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Safety, Tolerability and Efficacy of LiRIS® 400 mg in Women With Interstitial Cystitis Followed by an Open Label Extension

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.

The study is conducted in 2 parts: a randomized, blinded part in which subjects are assigned randomly (by chance) to LiRIS 400 mg or LiRIS placebo; subjects who complete this part and are eligible to continue, may participate in the open-label part in which all subjects receive LiRIS 400 mg.

In both parts of the study (blinded and open-label), LiRIS is inserted into the bladder during cystoscopy, remains in the bladder for 14 days, and is removed during cystoscopy. In addition to the 14 day period with the LiRIS/LiRIS Placebo, there is a screening period of up to 2 weeks and a follow up period of 4 weeks.

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