Safety Study of LiRIS in Interstitial Cystitis (IC) Patients

Study Overview
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Brief Summary
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The purpose of this study is primarily to evaluate the safety and tolerability of two dose levels of an investigational drug-delivery system (LiRIS) in patients who have moderate to severe symptoms of interstitial cystitis.

Detailed Description
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Approximately 20 female patients with interstitial cystitis will be enrolled in this study at multiple centers in Canada. LiRIS is being developed to provide drug therapy directly into the urinary bladder. LiRIS contains Lidocaine, a marketed drug (approved by Health Canada) which is commonly used for local (skin or oral)anaesthesia. LiRIS is designed to release a controlled amount of lidocaine while in the bladder over a 2 week period. Two dose groups of approximately 10 patients per group will be enrolled into the study; the first group of patients will receive low dose LiRIS, and the second group will receive high dose LiRIS. All patients receive LiRIS treatment for 14 days, and clinic follow-up at 7 and 14 days after treatment. Additional telephone follow-up occurs at approximately 6 and 10 weeks after LiRIS treatment. The maximum duration of participation, including a screening period of up to 14 days, will be 104 days.

Official Title
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Phase 1B Pilot Safety Study of LiRIS-TM, A Novel Bladder Drug Delivery Platform in Patients With Interstitial Cystitis

Conditions
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Interstitial Cystitis

Intervention / Treatment
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* Drug: LiRIS low dose and LiRIS high dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients ≥ 18 years of age If of child-bearing potential, agrees to use effective contraception defined by protocol Capable of understanding and completing symptom diaries and questionnaires as required in the study Diagnosed with IC, as defined by protocol criteria Exclusion Criteria: Bladder or urethra anatomical feature that, in the opinion of the investigator, might prevent the safe placement, indwelling use, or removal of LiRIS History or presence of any medical condition that would interfere with ability to assess symptoms Pregnant or lactating patients

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

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LiRIS low dose<br>The first dose group of approximately 10 patients receive low dose LiRIS on Day 1 to Day 14. | Drug: LiRIS low dose and LiRIS high dose<br>* Drug delivery system containing lidocaine; LiRIS (low or high dose) is inserted into bladder via cystoscopy on Day 1 and removed via cystoscopy on Day 14. Designed to release lidocaine over a 14 day period.<br>|
| Experimental: LiRIS high dose<br>The second dose group of approximately 10 patients receive high dose LiRIS on Day 1 to Day 14. | Drug: LiRIS low dose and LiRIS high dose<br>* Drug delivery system containing lidocaine; LiRIS (low or high dose) is inserted into bladder via cystoscopy on Day 1 and removed via cystoscopy on Day 14. Designed to release lidocaine over a 14 day period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cystoscopic examination |  | Days 1 and 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bladder pain |  | During and following treatment; study days 1 to 90 |