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

Allergan

Status and phase: Terminated; Phase 2

Conditions: Interstitial Cystitis

Treatments: Drug: LiRIS 400 mg; Other: LiRIS Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01824303

TAR-100-202

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 31 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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31 participants in 2 patient groups, including a placebo group

LiRIS 400 mg

Experimental group

Description:

LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days. If eligible, participants could participate in the Open Label Extension where all participants were treated with LiRIS 400 mg.

Treatment:

Drug: LiRIS 400 mg

LiRIS Placebo

Placebo Comparator group

Description:

LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days. If eligible, participants could participate in the Open Label Extension where all participants were treated with LiRIS 400 mg.

Treatment:

Other: LiRIS Placebo