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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
TARIS Biomedical, Inc.
ClinicalTrials.gov Identifier:
NCT01879683
First received: June 10, 2013
Last updated: May 8, 2014
Last verified: May 2014
  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 TARIS Biomedical, Inc.:

Primary Outcome Measures:
  • Change from Baseline in appearance of Hunner's Lesion. [ Time Frame: Study Day 14 or 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in subject reported IC symptoms (bladder pain, urinary frequency) [ Time Frame: Screen (Day -5 to -1); during treatment (Day 0 - 14) and on designated days during follow up period of 4 weeks after treatment. ] [ Designated as safety issue: No ]
    Subjects rate symptom of bladder pain for 5 days during screening, daily during treatment (study days 0 to 14), and for 3 days prior to follow up visits at 1,2, and 4 weeks after treatment. Subjects also record each daytime and night time void for 3 days during screening, and for 3 days prior to visits on study days 7 and 14, and the follow up visits at 1,2, and 4 weeks after treatment.


Estimated Enrollment: 10
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 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
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, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
TARIS Biomedical, Inc.
Investigators
Principal Investigator: Kenneth Peters, MD William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: TARIS Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT01879683     History of Changes
Other Study ID Numbers: TAR-100-105
Study First Received: June 10, 2013
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by TARIS Biomedical, Inc.:
Hunner's lesion

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

ClinicalTrials.gov processed this record on July 24, 2014