A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of LiRIS® 400 mg in Women With Ulcerative Interstitial Cystitis
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14
Study Overview
Brief Summary
The purpose of the study is to evaluate if LiRIS 400 mg is safe and tolerable when administered to women with Interstitial Cystitis with Hunner's lesions, and to evaluate any change in the bladder or in IC symptoms, following LiRIS administration.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women age 18 and older
- •Interstitial Cystitis with history of Hunner's lesions in the bladder
- •Moderate to severe bladder discomfort
- •Confirmation of Hunner's lesions in Bladder
- •Able to report symptom (pain and voiding frequency) in a diary throughout the study
Exclusion Criteria
- •Pregnant women
- •History or presence of bladder cancer
- •History or presence of any condition that would make it difficult to evaluate bladder symptoms
Arms & Interventions
LiRIS® 400 mg
LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
Intervention: LiRIS® 400 mg (Drug)
Outcomes
Primary Outcomes
Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14
Time Frame: Baseline, Day 14
The appearance of the Hunner's lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR)=presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either: i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal.
Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28
Time Frame: Baseline, Day 28
The appearance of the Hunner's lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR) = presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal.
Secondary Outcomes
- Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain(Baseline, during treatment (Days 7, 14, 20, 28) and during follow up (Weeks 1, 2, 4, 8, 12))
- Change From Baseline in Patient Reported IC Symptom: Daily Total Voids(Baseline, during treatment (Days 7, 14, 20, 28) and during follow-up (Weeks 1, 2, 4, 8, 12))