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

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

MedlinePlus related topics:

Interstitial Cystitis

ChemIDplus related topics:

Chondroitin Chondroitin sulfates Translagen

U.S. FDA Resources

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.

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
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 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

	Kitchener, Ontario, Canada

	Toronto, Ontario, Canada

	Barrie, Ontario, Canada

	Brantford, Ontario, Canada

	Newmarket, Ontario, Canada

	Kingston, Ontario, Canada

	Thunder Bay, Ontario, Canada

	Guelph, Ontario, Canada

Sponsors and Collaborators

Watson Pharmaceuticals

Investigators


Study Director:	Kamal Nazzal, MD	Watson Pharmaceuticals

More Information

Responsible Party:	Watson Laboratories Inc ( Gary Hoel Ph.D. Executive Director )
Study ID Numbers:	UR07001
First Received:	September 7, 2007
Last Updated:	February 18, 2008
ClinicalTrials.gov Identifier:	NCT00527917
Health Authority:	Canada: Health Canada

Keywords provided by Watson Pharmaceuticals:

IC/PBS

Interstitial Cystitis/Painful Bladder Syndrome

Study placed in the following topic categories:

Cystitis, Interstitial

Urologic Diseases

Urinary Bladder Diseases

Cystitis

Pain

Additional relevant MeSH terms:

Pathologic Processes

Disease

Syndrome

ClinicalTrials.gov processed this record on October 16, 2008

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