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Sponsored by: |
Capital District Health Authority, Canada |
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Information provided by: | Capital District Health Authority, Canada |
ClinicalTrials.gov Identifier: | NCT00317070 |
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 |
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Interstitial Cystitis Bladder Diseases |
Drug: dimethyl sulfoxide Drug: IC Cocktail |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 40 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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DMSO: Active Comparator
Intravesical installation
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Drug: dimethyl sulfoxide
intravesical installation 50 ml
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Cocktail: Experimental |
Drug: IC Cocktail
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jerzy Gajewski, MD, FRCSC | 902-473-8679 | jgajew@dal.ca |
Contact: Jacob Puthenparumpil, MD | 902-473-3844 | jputhenp@dal.ca |
Canada, Nova Scotia | |
Dept. of Urology, Queen Elizabeth II Health Sciences Center | Recruiting |
Halifax, Nova Scotia, Canada, B3H 3A7 | |
Principal Investigator: Jerzy Gajewski, MD, FRCSC | |
Sub-Investigator: Jacob Puthenparumpil, MD | |
Sub-Investigator: Greg Bailly, MD, FRCSC | |
Sub-Investigator: Swarna Weerasinghe, PhD | |
Sub-Investigator: Stephen Steele, MD |
Principal Investigator: | Jerzy Gajewski, MD, FRCSC | Capital District Health Authority |
Responsible Party: | Capital District Health Authority, Canada ( Jerzy B Gajewski ) |
Study ID Numbers: | CDHA010 |
Study First Received: | April 20, 2006 |
Last Updated: | May 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00317070 |
Health Authority: | Canada: Health Canada |
PBS/IC Painful bladder syndrome including Interstitial cystitis |
Cystocele Hydrocortisone Cortisol succinate Urinary Bladder Diseases Lidocaine Cystitis Pain |
Calcium heparin Dimethyl Sulfoxide Cystitis, Interstitial Urologic Diseases Gentamicins Hydrocortisone acetate Heparin |
Antioxidants Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action Syndrome |
Physiological Effects of Drugs Free Radical Scavengers Protective Agents Cryoprotective Agents Pharmacologic Actions |