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OpenTrials
Completed

NCT Number: NCT00919113

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

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.

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Key information

Conditions

Interstitial Cystitis Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Painful Bladder Syndrome Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Boulder, Colorado, United States

Loading trial locations.

About this study

Multi-center, randomized, double-blind, parallel, 8 weekly instillations over a 7-week period with post-treatment follow-up for an additional 19 weeks for a total study length of 26 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Are a female, 18 years or older
  • Have been diagnosed with IC/PBS
  • Are willing to provide written informed consent and authorization to disclose after being fully informed of the risks of participation

Exclusion criteria

  • Are lactating females
  • Have previously received investigational products or devices within 30 days of screening
  • Have previously received Uracyst
  • Are currently receiving therapy with Interstim®
  • Have any other condition/disease which, in the opinion of the investigator, could compromise subject safety or confound the interpretation of study results
  • Are unable or unwilling to comply with protocol requirements

Treatment and study plan

2% sodium chondroitin sulfate

Drug

Weekly 20 mL Intravesical instillation

Other names: Uracyst

Placebo

Drug

The identical buffer used in Uracyst for the same administration

Other names: buffer

Primary outcomes

  1. Global Response Assessment (GRA) Responders at Week 11.

    Time frame: at week 11

    subjects that indicated "markedly improved" or "moderately improved" on the GRA, LOCF

Secondary outcomes

  1. Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11.

    Time frame: at week 11

    Subjects that exhibited at least a 30% improvement from baseline in their total ICSI score, LOCF

Sponsors and collaborators

Lead sponsor

Watson Pharmaceuticals

Industry

Registry information

Official study title

A Multi-Center, Randomized, Double-Blind, Parallel Group Evaluation of the Effectiveness and Safety of Uracyst® Compared to Inactive Control in Subjects With Interstitial Cystitis/Painful Bladder Syndrome

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 12, 2009
Registry last updated
May 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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