URACYST® For the Treatment of GAG Deficient Interstitial Cystitis
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.
|Painful Bladder Syndrome Interstitial Cystitis||Device: Uracyst||Phase 2 Phase 3|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||URACYST® For the Treatment of GAG Deficient Interstitial Cystitis|
- Percent responders to treatment compared to baseline [ Time Frame: 6 weeks ]
- Improvement in individual IC symptoms during the treatment [ Time Frame: 12 weeks ]
- Change in Patient Symptom/Problem Index scores [ Time Frame: 12 Weeks ]
- Change in patient condition every month [ Time Frame: Monthly ]
- The safety of the study product will be evaluated [ Time Frame: Monthly ]
|Study Start Date:||September 2005|
|Study Completion Date:||February 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
2% weekly for 6 weeks, monthly for 4 months
Other Name: chondroitin sulphate
The primary efficacy endpoint will be the percent responders to treatment as indicated by improvement on a seven-point Patient Global Assessment scale at week 10 (after 6 treatments) compared to baseline. The patient evaluates the overall change in their condition as markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse or markedly worse.
Secondary efficacy objectives will be as follows:
Improvement in individual IC symptoms during the treatment period and at week 10 (after 6 treatments) compared to baseline.
Pain and urgency scores (0-10 cm VAS) will be obtained using patient on-site questionnaires prior to first treatment (baseline), and again for weeks 4, 6, 10, 14, 18, 22 and 24.
Change in Patient Symptom/Problem Index scores over the course of the treatment until the end of study (week 24) compared to baseline.
The validated O'Leary Symptom Problem/Index will be completed prior to first treatment (baseline) and again for weeks 4, 6, 10, 14, 18, 22 and 24.
The validated PUF questionnaire will be completed prior to first treatment (baseline) and again for weeks 4, 6, 10, 14, 18, 22 and 24.
- Change in patient condition every month throughout the therapy and treatment follow-up.
In addition to measuring the change in patient condition at week 14, the Patient Global Assessment will be completed at weeks 4, 6, 10, 14, 18, 22 and 24.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150488
|Centre for Advanced Urological Research, Kingston General Hospital|
|Kingston, Ontario, Canada, K7L 3N6|
|Principal Investigator:||Curtis Nickel, MD FRCSC||Queen's University|