Safety, Tolerability and Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis



Status:Terminated
Conditions:Other Indications, Urology
Therapuetic Areas:Nephrology / Urology, Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2013
End Date:December 2014

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A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Safety, Tolerability and Efficacy of LiRIS® 400 mg in Women With Interstitial Cystitis Followed by an Open Label Extension

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 following LiRIS administration.

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 continue, may participate in the open-label part in which all subjects
receive LiRIS 400 mg.

In both parts of the study (blinded and open-label), LiRIS is inserted into the bladder
during cystoscopy, remains in the bladder for 14 days, and is removed during cystoscopy. In
addition to the 14 day period with the LiRIS/LiRIS Placebo, there is a screening period of
up to 2 weeks and a follow up period of 4 weeks.

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
We found this trial at
16
sites
Abbotsford, British Columbia
1447
mi
from
Abbotsford,
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545 Health Blvd.
Daytona Beach, Florida 32114
386-239-8535
1129
mi
from
Daytona Beach, FL
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
1063
mi
from
Charleston, SC
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
895
mi
from
Cleveland, OH
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Glendora, California 91741
1146
mi
from
Glendora, CA
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737
mi
from
Grand Rapids, MI
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Greensboro, North Carolina
1001
mi
from
Greensboro, NC
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
190
mi
from
Kansas City, KS
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777
mi
from
Knoxville, TN
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823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
1099
mi
from
Myrtle Beach, SC
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1303
mi
from
New Hyde Park, NY
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1289
mi
from
Newburgh, NY
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Overland Park, Kansas 66209
190
mi
from
Overland Park, KS
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243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
1294
mi
from
Poughkeepsie, NY
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Royal Oak, Michigan 48073
839
mi
from
Royal Oak, MI
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Winston-Salem, North Carolina 27157
976
mi
from
Winston-Salem, NC
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