Status:
TERMINATED
Safety, Tolerability and Efficacy Study of LiRIS® 400 mg 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 purposes of the study is to determine if LiRIS®, an investigational drug-delivery system, is safe and tolerable in women with Interstitial Cystitis (IC), and to evaluate any change in IC symptoms ...
Detailed Description
The study is conducted in 2 parts: a randomized, blinded part in which subjects are assigned randomly (by chance) to LiRIS 400 mg or LiRIS placebo; subjects who complete this part and are eligible to ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Blinded study:
- Women age 18 and over
- Diagnosed with Interstitial Cystitis as defined by protocol
- Able to report IC symptoms of bladder pain, voiding habits, as required by protocol, and record in diary
- Able to comply with visit schedule and diary completion at home
- Open-label Extension:
- Must have completed the blinded study prior to screening for the Open-label extension
- Exclusion Criteria (Blinded and Open-Label Extension):
- Pregnant or lactating women
- History or presence of any condition that would make it difficult to accurately evaluate bladder symptoms
- Bladder or urethral abnormality that would prevent safe insertion of investigational product
- Requiring medication not allowed per study protocol
Exclusion
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01824303
Start Date
March 1 2013
End Date
December 1 2014
Last Update
January 26 2016
Active Locations (17)
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1
Citrus Valley Medical Research , Inc.
Glendora, California, United States, 91741
2
Atlantic Urological Associates
Daytona Beach, Florida, United States, 32114
3
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
4
The UrogynecologyCenter, LLC
Overland Park, Kansas, United States, 66209-2002