Safety Study of LiRIS in Interstitial Cystitis (IC) Patients

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is primarily to evaluate the safety and tolerability of two dose levels of an investigational drug-delivery system (LiRIS) in patients who have moderate to severe symptoms of interstitial cystitis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Collaborator: TARIS Biomedical, Inc.

Criteria

Inclusion Criteria:

• Female patients ≥ 18 years of age

• If of child-bearing potential, agrees to use effective contraception defined by protocol

• Capable of understanding and completing symptom diaries and questionnaires as required in the study

• Diagnosed with IC, as defined by protocol criteria

Exclusion Criteria:

• Bladder or urethra anatomical feature that, in the opinion of the investigator, might prevent the safe placement, indwelling use, or removal of LiRIS

• History or presence of any medical condition that would interfere with ability to assess symptoms

• Pregnant or lactating patients