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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.

NCT00527917 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2009-12-09

No results posted yet for this study

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

Interventions

DEVICE

placebo

bladder instillation

DEVICE

Uracyst

20 ml sterile solution for weekly intravesical instillation

Sponsors & Collaborators

  • Watson Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Keshava Kumar, PhD · Watson Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-06-30
Completion
2008-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00527917 on ClinicalTrials.gov