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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

NCT ID: NCT01879683

Last Updated: 2015-12-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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Chronic Interstitial Cystitis

Keywords

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Hunner's lesion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

LiRIS® 400 mg

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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TARIS Biomedical, Inc.

INDUSTRY

Sponsor Role collaborator

Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenneth Peters, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

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Advance Urology Institute

Daytona Beach, Florida, United States

Site Status

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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TAR-100-105

Identifier Type: -

Identifier Source: org_study_id