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| Sponsor: | Capital District Health Authority, Canada |
|---|---|
| Information provided by: | Capital District Health Authority, Canada |
| ClinicalTrials.gov Identifier: | NCT00317070 |
Purpose
The primary objective of this study is to evaluate the efficacy and tolerability of the intravesical cocktail and its comparison with intravesical DMSO in a controlled trial for the treatment of painful bladder syndrome including interstitial cystitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Interstitial Cystitis Bladder Diseases |
Drug: dimethyl sulfoxide Drug: IC Cocktail |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Trial to Evaluate the Efficacy and Tolerability of Intravesical Cocktail and Comparison With Intravesical Dimethyl Sulfoxide (DMSO) for the Treatment of Painful Bladder Syndrome Including Interstitial Cystitis (PBS/IC) |
| Enrollment: | 10 |
| Study Start Date: | April 2006 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: DMSO
Intravesical installation
|
Drug: dimethyl sulfoxide
intravesical installation 50 ml
|
| Experimental: Cocktail |
Drug: IC Cocktail
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada, Nova Scotia | |
| Dept. of Urology, Queen Elizabeth II Health Sciences Center | |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Principal Investigator: | Jerzy Gajewski, MD, FRCSC | Capital District Health Authority, Canada |
More Information
| Responsible Party: | Jerzy B Gajewski, Capital District Health Authority, Canada |
| ClinicalTrials.gov Identifier: | NCT00317070 History of Changes |
| Other Study ID Numbers: | CDHA010 |
| Study First Received: | April 20, 2006 |
| Last Updated: | May 8, 2009 |
| Health Authority: | Canada: Health Canada |
|
PBS/IC Painful bladder syndrome including Interstitial cystitis |
|
Urinary Bladder Diseases Cystitis Cystitis, Interstitial Urologic Diseases Dimethyl Sulfoxide Free Radical Scavengers |
Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cryoprotective Agents Protective Agents Physiological Effects of Drugs |