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

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

This study has been completed.

Study NCT00527917. Last updated on November 6, 2008. Information provided by Watson Pharmaceuticals

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

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.

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

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 Measure ^†

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 ]

Condition ^†

Interstitial Cystitis

Intervention ^†

Device: Uracyst
Device: placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

September 2007

Completion Date

September 2008

Eligibility 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Canada

Administrative Information Fields

NCT ID ^†

NCT00527917

Organization ID

UR07001

Secondary IDs ^††

Study Sponsor ^†

Watson Pharmaceuticals

Collaborators ^††

Investigators ^†

Study Director:

Keshava Kumar, PhD

Watson Pharmaceuticals

Information Provided By

Watson Pharmaceuticals

Verification Date

November 2008

First Received Date ^†

September 7, 2007

Last Updated Date

November 6, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.