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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

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Allergan

Status and phase

Completed
Phase 1

Conditions

Chronic Interstitial Cystitis

Treatments

Drug: LiRIS® 400 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01879683
TAR-100-105

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

LiRIS® 400 mg
Experimental group
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.
Treatment:
Drug: LiRIS® 400 mg

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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