A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC) and Hunner's Lesions

Phase 1

Completed

• Conditions: Chronic Interstitial Cystitis
• Interventions: Drug: LiRIS® 400 mg

• Registration Number: NCT01879683
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-06-13
• Study First Posted: 2013-06-18
• Study Start: 2013-07
• Primary Completion: 2014-05
• Study Completion: 2014-06
• Status Verified: 2015-11
• Results First Submitted: 2015-11-13
• Results First Submitted QC: 2015-11-13
• Last Update Submitted: 2015-11-13
• Results First Posted: 2015-12-18
• Last Update Posted: 2015-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LiRIS® 400 mg	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14	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	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 Outcome Measures

Name	Time	Method
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)	Participants rated symptom bladder pain averaged over the previous 3 days using an 11-point numeric rating scale where: 0=no pain to 10=worst pain imaginable. A negative change from Baseline indicates improvement.
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)	The number of day-time voidings and the number of night-time voidings were averaged over a period of 3 full days and nights. A negative change from Baseline indicates improvement

Trial Locations

Locations (2)

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

Advance Urology Institute; 🇺🇸 Daytona Beach, Florida, United States