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Efficacy and Safety Study of Uracyst to Treat Interstitial Cystitis/Painful Bladder Syndrome

NCT00919113 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2013-05-03

Study results available
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Summary

A new device for interstitial cystitis is compared to inactive control to determine if it is safe and effective. The study lasts approximately 7 weeks with a 19-week follow-up period.

Conditions

  • Interstitial Cystitis
  • Painful Bladder Syndrome

Interventions

DRUG

2% sodium chondroitin sulfate

Weekly 20 mL Intravesical instillation

DRUG

Placebo

The identical buffer used in Uracyst for the same administration

Sponsors & Collaborators

  • Watson Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Lawrence A Hill, PharmD, MBA · Watson Laboratories, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT00919113 on ClinicalTrials.gov