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

NCT00527917 | Completed Phase 2

• 1 other identifier: UR07001
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 13

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.

Conditions

Interstitial Cystitis

Keywords

IC/PBS; Interstitial Cystitis/Painful Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

• Change from baseline to 6 weeks in Global Response Assessment instrument (GRA)score. The GRA evaluates symptoms of intersticial cystitis

  Baseline to 6 weeks

Secondary Outcomes (1)

• Adverse event assessments

  Throughout the study, first instillation to Week 12

Study Arms (2)

Uracyst

EXPERIMENTAL

Sodium chondroitin sulfate

Device: Uracyst

Placebo

PLACEBO COMPARATOR

placebo

Device: placebo

Interventions

placebo DEVICE

bladder instillation

Also known as: device vehicle

Placebo

Uracyst DEVICE

20 ml sterile solution for weekly intravesical instillation

Also known as: sodium chondroitin sulfate

Uracyst

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Watson Pharmaceuticals: lead

Study Sites (13)

Unknown Facility

Surrey, British Columbia, Canada

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Unknown Facility

Victoria, British Columbia, Canada

Location

Unknown Facility

Kentville, Nova Scotia, Canada

Location

Unknown Facility

Barrie, Ontario, Canada

Location

Unknown Facility

Brantford, Ontario, Canada

Location

Unknown Facility

Guelph, Ontario, Canada

Location

Unknown Facility

Kingston, Ontario, Canada

Location

Unknown Facility

Kitchener, Ontario, Canada

Location

Unknown Facility

Newmarket, Ontario, Canada

Location

Unknown Facility

North Bay, Ontario, Canada

Location

Unknown Facility

Thunder Bay, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Keshava Kumar, PhD

  Watson Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 7, 2007
• First Posted: September 11, 2007
• Study Start: September 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 9, 2009

Record last verified: 2009-12

Locations

CA (13)