Efficacy and Safety Study of Uracyst to Treat Interstitial Cystitis/Painful Bladder Syndrome

Phase 2CompletedNCT00919113

Watson Pharmaceuticals98 enrolled

Overview

A new device for interstitial cystitis is compared to inactive control to determine if it is safe and effective. The study lasts approximately 7 weeks with a 19-week follow-up period.

Multi-center, randomized, double-blind, parallel, 8 weekly instillations over a 7-week period with post-treatment follow-up for an additional 19 weeks for a total study length of 26 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Interstitial Cystitis Painful Bladder Syndrome

Interventions

2% sodium chondroitin sulfateDRUG

Weekly 20 mL Intravesical instillation

PlaceboDRUG

The identical buffer used in Uracyst for the same administration

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Are a female, 18 years or older * Have been diagnosed with IC/PBS * Are willing to provide written informed consent and authorization to disclose after being fully informed of the risks of participation Exclusion Criteria: * Are lactating females * Have previously received investigational products or devices within 30 days of screening * Have previously received Uracyst * Are currently receiving therapy with Interstim® * Have any other condition/disease which, in the opinion of the investigator, could compromise subject safety or confound the interpretation of study results * Are unable or unwilling to comply with protocol requirements

Locations (20)

Unnamed facility

Boulder, Colorado, United States

Unnamed facility

Denver, Colorado, United States

Outcomes

Primary Outcomes

Global Response Assessment (GRA) Responders at Week 11.

subjects that indicated "markedly improved" or "moderately improved" on the GRA, LOCF

Time frame: at week 11

Secondary Outcomes

Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11.

Subjects that exhibited at least a 30% improvement from baseline in their total ICSI score, LOCF

Time frame: at week 11

Data from ClinicalTrials.gov

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