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

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

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.

Study Overview

• Status: Completed
• Conditions: Interstitial Cystitis; Painful Bladder Syndrome
• Intervention / Treatment: Drug: 2% sodium chondroitin sulfate; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80304
    • Denver, Colorado, United States, 80211
  • Connecticut
    • Farmington, Connecticut, United States, 06032
  • Florida
    • Plantation, Florida, United States, 33317
    • Wellington, Florida, United States, 33414
  • Georgia
    • Columbus, Georgia, United States, 31904
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
  • Illinois
    • Evanston, Illinois, United States, 60201
    • Melrose Park, Illinois, United States, 60160
  • Michigan
    • Royal Oak, Michigan, United States, 48073
  • Nevada
    • Las Vegas, Nevada, United States, 89148
  • New Jersey
    • Englewood, New Jersey, United States, 07601
    • Sewell, New Jersey, United States, 08080
    • Westampton, New Jersey, United States, 08060
  • New York
    • Albany, New York, United States, 12206
    • Poughkeepsie, New York, United States, 12601
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
  • Washington
    • Mountlake Terrace, Washington, United States, 98043

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 8 weekly bladder instillations of Uracyst; 20 mL Uracyst (2% sodium chondroitin sulfate) per instillation; 8 instillations over a 7-week period	Drug: 2% sodium chondroitin sulfate; Weekly 20 mL Intravesical instillation; Other Names: Uracyst
Placebo Comparator: 8 weekly bladder instillations of inactive control; 20 mL inactive control buffer (phosphate-buffered saline); 8 instillations over a 7-week period	Drug: Placebo; The identical buffer used in Uracyst for the same administration; Other Names: buffer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Response Assessment (GRA) Responders at Week 11.	subjects that indicated "markedly improved" or "moderately improved" on the GRA, LOCF	at week 11

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Watson Pharmaceuticals
• Investigators: Study Director: Lawrence A Hill, PharmD, MBA, Watson Laboratories, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: June 11, 2009
• First Submitted That Met QC Criteria: June 11, 2009
• First Posted (Estimate): June 12, 2009

Study Record Updates

• Last Update Posted (Estimate): May 3, 2013
• Last Update Submitted That Met QC Criteria: May 1, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: IC/PBS; Bladder Pain; GAG replacement therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Disease; Syndrome; Cystitis; Pain; Cystitis, Interstitial
• Other Study ID Numbers: UR08004