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

Interstitial Cystitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919113
• Other study ID #: UR08004
• Status: Completed
• Phase: Phase 2
• First received: June 11, 2009
• Last updated: May 1, 2013
• Start date: July 2009
• Est. completion date: December 2010

Study information

• Verified date: May 2013
• Source: Watson Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Pain
• Painful Bladder Syndrome
• Syndrome

Intervention

Drug:
• 2% sodium chondroitin sulfate
Weekly 20 mL Intravesical instillation
• Placebo
The identical buffer used in Uracyst for the same administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Watson Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Response Assessment (GRA) Responders at Week 11.	subjects that indicated "markedly improved" or "moderately improved" on the GRA, LOCF	at week 11	No
Secondary	Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11.	Subjects that exhibited at least a 30% improvement from baseline in their total ICSI score, LOCF	at week 11	No