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

A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of LiRIS® 400 mg in Women With Ulcerative Interstitial Cystitis

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 Overview

• Status: Completed
• Conditions: Chronic Interstitial Cystitis
• Intervention / Treatment: Drug: LiRIS® 400 mg

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Advance Urology Institute
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: LiRIS® 400 mg; LiRIS® 400 mg is a drug-device combination product which is placed in the bladder during cystoscopy, remains in the bladder for up to 14 days gradually releasing lidocaine, and removed from the bladder via cystoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at 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.	Baseline, Day 14
Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at 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.	Baseline, Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain	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.	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	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	Baseline, during treatment (Days 7, 14, 20, 28) and during follow-up (Weeks 1, 2, 4, 8, 12)

Collaborators and Investigators

• Sponsor: Allergan
• Collaborators: TARIS Biomedical, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: June 10, 2013
• First Submitted That Met QC Criteria: June 13, 2013
• First Posted (ESTIMATE): June 18, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 18, 2015
• Last Update Submitted That Met QC Criteria: November 13, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Hunner's lesion
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Cystitis; Cystitis, Interstitial
• Other Study ID Numbers: TAR-100-105