Safety Study of LiRIS in Interstitial Cystitis (IC) Patients
Phase 1B Pilot Safety Study of LiRIS-TM, A Novel Bladder Drug Delivery Platform in Patients With Interstitial Cystitis
1 other identifier
interventional
18
1 country
3
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 interstitial cystitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2010
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2010
CompletedFirst Posted
Study publicly available on registry
June 25, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedNovember 25, 2014
November 1, 2014
1.2 years
June 23, 2010
November 24, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Cystoscopic examination
Days 1 and 14
Secondary Outcomes (1)
Bladder pain
During and following treatment; study days 1 to 90
Study Arms (2)
LiRIS low dose
EXPERIMENTALThe first dose group of approximately 10 patients receive low dose LiRIS on Day 1 to Day 14.
LiRIS high dose
EXPERIMENTALThe second dose group of approximately 10 patients receive high dose LiRIS on Day 1 to Day 14.
Interventions
Drug delivery system containing lidocaine; LiRIS (low or high dose) is inserted into bladder via cystoscopy on Day 1 and removed via cystoscopy on Day 14. Designed to release lidocaine over a 14 day period.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
- TARIS Biomedical, Inc.collaborator
Study Sites (3)
Dr. Steinhoff Clinical Research
Victoria, British Columbia, V8V 3N1, Canada
Queen Elizabeth II Health Sciences Centre, Halifax Infirmary
Halifax, Nova Scotia, B3H 3A7, Canada
Centre for Applied Urological Research
Kingston, Ontario, K7L 3J7, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Curtis Nickel, MD
Queen's University/Kingston General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2010
First Posted
June 25, 2010
Study Start
July 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
November 25, 2014
Record last verified: 2014-11