Status:
TERMINATED
Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis
Lead Sponsor:
Allergan
Collaborating Sponsors:
TARIS Biomedical, Inc.
Conditions:
Interstitial Cystitis
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if LiRIS®, an investigational drug-delivery system, is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is inserted into the bladder ...
Detailed Description
The study is conducted in 2 parts - a randomized, blinded part in which patients are randomly assigned to one of 3 possible arms (LiRIS® - contains lidocaine), LiRIS Placebo (LiRIS with inactive subst...
Eligibility Criteria
Inclusion
- Women age 18 and over
- Diagnosed with Interstitial Cystitis as defined by protocol
- Able and willing to complete questionnaires and diary
- Able to comply with visit schedule including Day 14 Removal visit
- Completion of blinded study prior to enrolling in unblinded part of study
Exclusion
- Pregnant or lactating women
- Bladder or urethra anatomical feature that would prevent the safe indwelling or insertion of the investigational product
- History or presence of any condition that would make it difficult to evaluate symptoms
- Did not complete blinded study (unblinded part of study only)
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01475253
Start Date
November 1 2011
End Date
December 1 2012
Last Update
September 21 2015
Active Locations (29)
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1
Clinical Trials of Arizona
Glendale, Arizona, United States, 85306
2
Citrus Valley Medical Research, Inc
Glendora, California, United States, 91741
3
Stanford University Department of Urology
Stanford, California, United States, 94306
4
Genitourinary Surgical Consultants
Denver, Colorado, United States, 80220