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

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

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating Safety and Efficacy of LiRIS® 400 mg in Females With Interstitial Cystitis/Bladder Pain Syndrome

Conditions
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Cystitis, Interstitial, Painful Bladder Syndrome

Intervention / Treatment
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* Combination Product: LiRIS®
* Combination Product: LiRIS Placebo


Participation Criteria
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Eligibility Criteria
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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®

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)<br>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. | Combination Product: LiRIS®<br>* LiRIS® is a drug-device combination product which is placed in the bladder during cystoscopy and remains in the bladder, gradually releasing lidocaine until removed from the bladder via cystoscopy.<br>|
| Other: LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2)<br>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. | Combination Product: LiRIS®<br>* LiRIS® is a drug-device combination product which is placed in the bladder during cystoscopy and remains in the bladder, gradually releasing lidocaine until removed from the bladder via cystoscopy.<br>Combination Product: LiRIS Placebo<br>* LiRIS placebo is a drug-device combination product, matching the LiRIS® which is placed in the bladder during cystoscopy, remains in the bladder until removed from the bladder via cystoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up | The participant recorded their bladder pain over the previous 24-hour period in a 7-day pain assessment tool using an 11-point Numeric Rating Scale (NRS) (0 to 10) where 0=no pain to 10= worst pain. Pain data recorded over the 7-day period were averaged. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model with baseline value as a covariate and treatment group and stratification factors (age group: < 40 years or ≥ 40 years and baseline bladder pain NRS: ≤ 6 or > 6) as factors was used for analysis. | Baseline (Days -7 to 0) to Treatment 1 Week 4 |