A Pilot Clinical Investigation of the Efficacy and Safety of Uracyst® Versus Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome. - Full Text View

Sponsor:	Watson Pharmaceuticals
Information provided by:	Watson Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00527917

Purpose

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.

Condition	Intervention	Phase
Interstitial Cystitis	Device: Uracyst Device: placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Randomized, Double-Blind, Parallel Group Evaluation of the Efficacy and Safety of Uracyst® (Intravesical Sodium Chondroitin Sulfate) Versus Vehicle Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome.

Resource links provided by NLM:

MedlinePlus related topics: Interstitial Cystitis

Drug Information available for: Translagen Chondroitin Chondroitin sulfates

U.S. FDA Resources

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:

The primary objective of this study is to evaluate the efficacy of Uracyst® relative to vehicle placebo in patients with Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) using the Global Response Assessment instrument (GRA). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary objectives of this study are to evaluate the efficacy of Uracyst® by using additional efficacy instruments and to collect additional safety data on the device. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	September 2007
Study Completion Date:	September 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Uracyst	Device: Uracyst solution for bladder instillation
2: Placebo Comparator placebo	Device: placebo bladder instillation

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Are female of male patient 18 years or older
Have been previously diagnosed with IC/PBS.
Are willing to provide informed consent
Available for the duration of the study including treatment and follow-up (12 weeks)

Exclusion Criteria:

Pregnant or lactating female.
Are currently or have previously received investigational drugs within thirty (30) days of screening.
Previous therapy for IC/PBS
Have any medical condition/disease that could interfere with patient compliance or interfere with interpretation of the study results.
Are unable or unwilling to comply with protocol requirements
Are unable to read, understand, and provide written informed consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527917

Locations

Canada, British Columbia

Surrey, British Columbia, Canada

Vancouver, British Columbia, Canada

Victoria, British Columbia, Canada
Canada, Nova Scotia

Kentville, Nova Scotia, Canada
Canada, Ontario

Toronto, Ontario, Canada

Kitchener, Ontario, Canada

Barrie, Ontario, Canada

Guelph, Ontario, Canada

Brantford, Ontario, Canada

Newmarket, Ontario, Canada

Kingston, Ontario, Canada

Thunder Bay, Ontario, Canada

North Bay, Ontario, Canada

Sponsors and Collaborators

Watson Pharmaceuticals

Investigators

Study Director:

Keshava Kumar, PhD

Watson Pharmaceuticals

More Information

No publications provided

Responsible Party:	Watson Laboratories Inc ( Gary Hoel Ph.D. Executive Director )
Study ID Numbers:	UR07001
Study First Received:	September 7, 2007
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00527917 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Watson Pharmaceuticals:

IC/PBS
Interstitial Cystitis/Painful Bladder Syndrome

Additional relevant MeSH terms:

Cystitis, Interstitial
Pathologic Processes
Disease
Urologic Diseases

Syndrome
Urinary Bladder Diseases
Cystitis

ClinicalTrials.gov processed this record on November 30, 2009