Status:
COMPLETED
Safety Study of LiRIS in Interstitial Cystitis (IC) Patients
Lead Sponsor:
Allergan
Collaborating Sponsors:
TARIS Biomedical, Inc.
Conditions:
Interstitial Cystitis
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
Approximately 20 female patients with interstitial cystitis will be enrolled in this study at multiple centers in Canada. LiRIS is being developed to provide drug therapy directly into the urinary bla...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01150565
Start Date
July 1 2010
End Date
September 1 2011
Last Update
November 25 2014
Active Locations (3)
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1
Dr. Steinhoff Clinical Research
Victoria, British Columbia, Canada, V8V 3N1
2
Queen Elizabeth II Health Sciences Centre, Halifax Infirmary
Halifax, Nova Scotia, Canada, B3H 3A7
3
Centre for Applied Urological Research
Kingston, Ontario, Canada, K7L 3J7