Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® 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: | November 2011 |
End Date: | December 2012 |
A Phase 2a Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Safety, Tolerability and Efficacy of LiRIS® in Women With Interstitial Cystitis Followed by an Open Label Extension
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 via cystoscopy , remains in the bladder for 14 days, and is
removed via cystoscopy.
system, is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is
inserted into the bladder via cystoscopy , remains in the bladder for 14 days, and is
removed via cystoscopy.
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 substance) or Sham(Insertion procedure only with neither LiRIS nor
LiRIS Placebo), followed by an open extension part in which all patients are assigned to
receive LiRIS® (with lidocaine). In part 1 of the study, treatment is managed in a
double-blind manner for LiRIS® and LiRIS Placebo arms; and in a single-blind manner for the
Sham arm (e.g.,the study doctor will know the treatment assignment for patients assigned to
Sham).
All patients who complete part 1 of the study have the option to enter the extension.
randomly assigned to one of 3 possible arms (LiRIS® - contains lidocaine), LiRIS Placebo
(LiRIS with inactive substance) or Sham(Insertion procedure only with neither LiRIS nor
LiRIS Placebo), followed by an open extension part in which all patients are assigned to
receive LiRIS® (with lidocaine). In part 1 of the study, treatment is managed in a
double-blind manner for LiRIS® and LiRIS Placebo arms; and in a single-blind manner for the
Sham arm (e.g.,the study doctor will know the treatment assignment for patients assigned to
Sham).
All patients who complete part 1 of the study have the option to enter the extension.
Inclusion Criteria:
- 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 Criteria:
- 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)
We found this trial at
28
sites
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
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...
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