A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome

Allergan

Status and phase: Completed; Phase 2

Conditions: Cystitis, Interstitial; Painful Bladder Syndrome

Treatments: Combination Product: LiRIS®; Combination Product: LiRIS Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02411110

201025-002

Details and patient eligibility

About

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

Enrollment: 131 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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131 participants in 2 patient groups

LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)

Experimental group

Description:

Treatment Period 1: continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.

Treatment:

Combination Product: LiRIS®

LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2)

Other group

Description:

Treatment period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.

Treatment:

Combination Product: LiRIS®

Combination Product: LiRIS Placebo