Evaluation of Intravesical LP08 in Patients With Interstitial Cystitis/Painful Bladder Syndrome (NCT01393223) | Clinical Trial Compass
CompletedPhase 2
Evaluation of Intravesical LP08 in Patients With Interstitial Cystitis/Painful Bladder Syndrome
United States21 participantsStarted 2015-07-21
Plain-language summary
The purpose of this study is to assess the safety and tolerability of two doses of LP08 compared to placebo. Hypothesis: Safety of the LP-08 therapy will not be significantly different from the placebo group. Secondary Efficacy Endpoints: A matched-pair data analysis design will be employed, i.e. the measured outcomes will be subjects' improvements in quantitative and qualitative measures of the disease condition being assessed prior to and after LP-08 instillations at four and eight weeks follow-up visits
Who can participate
Age range18 Years ā 70 Years
SexALL
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Inclusion criteria
ā. Male or female at least 18 years of age
ā. IC/BPS diagnosed by a health care provider based the following criteria:
ā. Have had inadequate clinical responses with conservative treatments, which may include one or more of the following: 1) timed voiding and behavioral modification therapy, 2) dietary restrictions, 3) stress reduction and/or 5) oral therapy with any of the following medications:
ā. Women of childbearing potential: have a negative urine pregnancy test at screening, and must agree to use an acceptable from of contraception (oral contraceptives, intrauterine or double barrier methods), as agreed to by the investigator, during the study period
ā. Provide signed informed consent
ā. Subject agrees to be available for the follow-up evaluations as required by the protocol
Exclusion criteria
ā. Currently pregnant or breastfeeding, or plan to become pregnant during the course of the study
ā. Have received investigational products or devices within 30 days prior to screening visit
ā. Have received intravesical therapy or bladder hydrodistention within 30 days prior to screening visit. Intravesical instillations may include liquid or drug delivery devices, pentosan polysulfate sodium, lidocaine, steroid, heparin, chondroitin and any combination or additional formulation.
ā. Have participated in IC/BPS research trial within 90 days prior to screening visit or has not returned to baseline if participated in IC/BPS research trial greater than 90 days prior to screening visit
What they're measuring
1
Safety of Intravesical LP08: number/severity of adverse events
ā. Have received any of the following medication within 30 days of screening visit, unless such medications have been administered at a stable dose during this month and are expected to remain at a stable dose throughout the study:
ā. Have indicated use of \> 70 mg of morphine equivalents of opioids per week to control their IC/BPS pain within 30 days prior to screening, or are expected to require this level of IC/BPS pain control during the study period
ā. Previous augmentation cystoplasty, cystectomy, neurectomy (i.e., hypogastric nerve plexus ablation). Bladder botulinum toxin injections within nine months prior to screening.
ā. Sacral and/or pudendal nerve neuromodulation device (Interstim) within the last 6 months. Subjects would not be excluded if they had Interstim greater than 6 months ago and is on a stable setting within the past 90 days