Completed
A Multi-Center, Randomized, Double-Blind, Parallel Group Evaluation of the Effectiveness and Safety of Uracyst® Compared to Inactive Control in Subjects With Interstitial Cystitis/Painful Bladder Syndrome
What is being tested
2% sodium chondroitin sulfate
+ Placebo
Drug
Who is being recruted
Urogenital Diseases+5
+ Urinary Bladder Diseases
+ Cystitis
Over 18 Years
+9 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 2
Interventional
Study Start: July 2009
Summary
Principal SponsorWatson Pharmaceuticals
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2009
Actual date on which the first participant was enrolled.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.
Official TitleA Multi-Center, Randomized, Double-Blind, Parallel Group Evaluation of the Effectiveness and Safety of Uracyst® Compared to Inactive Control in Subjects With Interstitial Cystitis/Painful Bladder Syndrome
Principal SponsorWatson Pharmaceuticals
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
98 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Urogenital DiseasesUrinary Bladder DiseasesCystitisFemale Urogenital Diseases and Pregnancy ComplicationsUrologic DiseasesCystitis, InterstitialFemale Urogenital DiseasesMale Urogenital Diseases
Criteria
3 inclusion criteria required to participate
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
6 exclusion criteria prevent from participating
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®
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Experimental20 mL Uracyst (2% sodium chondroitin sulfate) per instillation; 8 instillations over a 7-week period
Group II
Placebo20 mL inactive control buffer (phosphate-buffered saline); 8 instillations over a 7-week period
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers