Back to resultsA Pilot Clinical Investigation of the Efficacy and Safety of Uracyst® Versus Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome.
Primary Purpose
Interstitial Cystitis
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
placebo
Uracyst
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Cystitis focused on measuring IC/PBS, Interstitial Cystitis/Painful Bladder Syndrome
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Uracyst
Placebo
Arm Description
Sodium chondroitin sulfate
placebo
Outcomes
Primary Outcome Measures
Change from baseline to 6 weeks in Global Response Assessment instrument (GRA)score. The GRA evaluates symptoms of intersticial cystitis
Secondary Outcome Measures
Adverse event assessments
Full Information
NCT ID
NCT00527917
First Posted
September 7, 2007
Last Updated
December 7, 2009
Sponsor
Watson Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00527917
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Watson Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis
Keywords
IC/PBS, Interstitial Cystitis/Painful Bladder Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Uracyst
Arm Type
Experimental
Arm Description
Sodium chondroitin sulfate
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Device
Intervention Name(s)
placebo
Other Intervention Name(s)
device vehicle
Intervention Description
bladder instillation
Intervention Type
Device
Intervention Name(s)
Uracyst
Other Intervention Name(s)
sodium chondroitin sulfate
Intervention Description
20 ml sterile solution for weekly intravesical instillation
Primary Outcome Measure Information:
Title
Change from baseline to 6 weeks in Global Response Assessment instrument (GRA)score. The GRA evaluates symptoms of intersticial cystitis
Time Frame
Baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Adverse event assessments
Time Frame
Throughout the study, first instillation to Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keshava Kumar, PhD
Organizational Affiliation
Watson Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Surrey
State/Province
British Columbia
Country
Canada
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Victoria
State/Province
British Columbia
Country
Canada
City
Kentville
State/Province
Nova Scotia
Country
Canada
City
Barrie
State/Province
Ontario
Country
Canada
City
Brantford
State/Province
Ontario
Country
Canada
City
Guelph
State/Province
Ontario
Country
Canada
City
Kingston
State/Province
Ontario
Country
Canada
City
Kitchener
State/Province
Ontario
Country
Canada
City
Newmarket
State/Province
Ontario
Country
Canada
City
North Bay
State/Province
Ontario
Country
Canada
City
Thunder Bay
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Pilot Clinical Investigation of the Efficacy and Safety of Uracyst® Versus Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome.
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