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

Interstitial Cystitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00527917
• Other study ID #: UR07001
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2007
• Last updated: December 7, 2009
• Start date: September 2007
• Est. completion date: September 2008

Study information

• Verified date: December 2009
• Source: Watson Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

Intervention

Device:
• placebo
bladder instillation
• Uracyst
20 ml sterile solution for weekly intravesical instillation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Watson Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to 6 weeks in Global Response Assessment instrument (GRA)score. The GRA evaluates symptoms of intersticial cystitis		Baseline to 6 weeks	No
Secondary	Adverse event assessments		Throughout the study, first instillation to Week 12	Yes