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

This study has been completed.
Sponsor:
Collaborator:
TARIS Biomedical, Inc.
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01879683
First received: June 10, 2013
Last updated: November 13, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention Phase
Chronic Interstitial Cystitis
Drug: LiRIS® 400 mg
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14 [ Time Frame: Baseline, Day 14 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, during treatment (Days 7, 14, 20, 28) and during follow up (Weeks 1, 2, 4, 8, 12) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, during treatment (Days 7, 14, 20, 28) and during follow-up (Weeks 1, 2, 4, 8, 12) ] [ Designated as safety issue: No ]
    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


Enrollment: 10
Study Start Date: July 2013
Study Completion Date: June 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01879683

Locations
United States, Florida
Advance Urology Institute
Daytona Beach, Florida, United States, 32114
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Allergan
TARIS Biomedical, Inc.
Investigators
Principal Investigator: Kenneth Peters, MD William Beaumont Hospitals
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01879683     History of Changes
Other Study ID Numbers: TAR-100-105 
Study First Received: June 10, 2013
Results First Received: November 13, 2015
Last Updated: November 13, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Allergan:
Hunner's lesion

Additional relevant MeSH terms:
Cystitis, Interstitial
Cystitis
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on December 08, 2016