CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 53 enrolled
Drug / intervention
Uracystdevice
Likely dose
Uracyst 2% intravesical instillation: weekly for 6 weeks, then monthly for 4 monthsAI-extracted
Key inclusion· 7
  • ✓Clinical diagnosis of interstitial cystitis confirmed by treating physician
  • ✓Female patients of legal majority age capable of informed consent
  • ✓Negative pregnancy test at baseline or prior surgical sterilization/condition preventing conception
  • ✓Sterile bacterial urine culture within 30 days prior to first treatment
Key exclusion· 15
  • ✕Pregnant or lactating women
  • ✕Received investigational drugs within 30 days prior to screening
  • ✕Prior or ongoing intravesical therapy (Uracyst, Cystistat, heparin, BCG)
  • ✕Concurrent systemic IC medications not stabilized for ≥3 months (antidepressants, antihistamines, hormonal agents)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00150488
NCT00150488N/ACompleted
CompareCT.gov

URACYST® For the Treatment of GAG Deficient Interstitial Cystitis

Dr. J. Curtis Nickel·interventional·Posted Sep 8, 2005·Updated Jul 27, 2023

In Brief

A clinical study evaluating Uracyst for Painful Bladder Syndrome and Interstitial Cystitis. Completed, enrolled 53 participants across 1 site.

Detailed Summary

This protocol describes a multi-centre, community based open label study designed to assess the efficacy and safety of intravesical sodium chrondroitin sulfate (Uracyst®) in the treatment of patients with a clinical diagnosis of interstitial cystitis (IC). The safety of the study product will be evaluated through the incidence of adverse events and from results of physical examinations and laboratory tests.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPainful Bladder Syndrome, Interstitial Cystitis
CountriesCanada
CollaboratorsStellar Pharmaceuticals

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2005
Enrollment StartSep 1, 2005
Primary CompletionJan 1, 2008
Study CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.8 years ago

Interventions

Uracystdevice

2% weekly for 6 weeks, monthly for 4 months