A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC) and Hunner's Lesions
Primary Purpose
Chronic Interstitial Cystitis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LiRIS® 400 mg
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Interstitial Cystitis focused on measuring Hunner's lesion
Eligibility Criteria
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
Sites / Locations
- Advance Urology Institute
- William Beaumont Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LiRIS® 400 mg
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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
Full Information
NCT ID
NCT01879683
First Posted
June 10, 2013
Last Updated
November 13, 2015
Sponsor
Allergan
Collaborators
TARIS Biomedical, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01879683
Brief Title
A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC) and Hunner's Lesions
Official Title
A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of LiRIS® 400 mg in Women With Ulcerative Interstitial Cystitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
Collaborators
TARIS Biomedical, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Interstitial Cystitis
Keywords
Hunner's lesion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LiRIS® 400 mg
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
LiRIS® 400 mg
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14
Description
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.
Time Frame
Baseline, Day 14
Title
Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28
Description
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.
Time Frame
Baseline, Day 28
Secondary Outcome Measure Information:
Title
Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain
Description
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.
Time Frame
Baseline, during treatment (Days 7, 14, 20, 28) and during follow up (Weeks 1, 2, 4, 8, 12)
Title
Change From Baseline in Patient Reported IC Symptom: Daily Total Voids
Description
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
Time Frame
Baseline, during treatment (Days 7, 14, 20, 28) and during follow-up (Weeks 1, 2, 4, 8, 12)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Peters, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advance Urology Institute
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC) and Hunner's Lesions
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