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This is a pilot clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive either an active product (Uracyst®) or placebo intravesically via a bladder catheter weekly for 6 weeks, followed by 6 weeks of follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uracyst | Experimental | Sodium chondroitin sulfate |
|
| Placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Device | bladder instillation |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to 6 weeks in Global Response Assessment instrument (GRA)score. The GRA evaluates symptoms of intersticial cystitis | Baseline to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event assessments | Throughout the study, first instillation to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keshava Kumar, PhD | Watson Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surrey | British Columbia | Canada | ||||
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| Uracyst | Device | 20 ml sterile solution for weekly intravesical instillation |
|
|
| Vancouver |
| British Columbia |
| Canada |
| Victoria | British Columbia | Canada |
| Kentville | Nova Scotia | Canada |
| Barrie | Ontario | Canada |
| Brantford | Ontario | Canada |
| Guelph | Ontario | Canada |
| Kingston | Ontario | Canada |
| Kitchener | Ontario | Canada |
| Newmarket | Ontario | Canada |
| North Bay | Ontario | Canada |
| Thunder Bay | Ontario | Canada |
| Toronto | Ontario | Canada |
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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