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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00919113
First received: June 11, 2009
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Interstitial Cystitis
Painful Bladder Syndrome
Drug: 2% sodium chondroitin sulfate
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • Global Response Assessment (GRA) Responders at Week 11. [ Time Frame: at week 11 ] [ Designated as safety issue: No ]
    subjects that indicated "markedly improved" or "moderately improved" on the GRA, LOCF


Secondary Outcome Measures:
  • Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11. [ Time Frame: at week 11 ] [ Designated as safety issue: No ]
    Subjects that exhibited at least a 30% improvement from baseline in their total ICSI score, LOCF


Enrollment: 98
Study Start Date: July 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: buffer

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919113

Locations
United States, Colorado
Boulder, Colorado, United States, 80304
Denver, Colorado, United States, 80211
United States, Connecticut
Farmington, Connecticut, United States, 06032
United States, Florida
Plantation, Florida, United States, 33317
Wellington, Florida, United States, 33414
United States, Georgia
Columbus, Georgia, United States, 31904
United States, Idaho
Coeur d'Alene, Idaho, United States, 83814
United States, Illinois
Evanston, Illinois, United States, 60201
Melrose Park, Illinois, United States, 60160
United States, Michigan
Royal Oak, Michigan, United States, 48073
United States, Nevada
Las Vegas, Nevada, United States, 89148
United States, New Jersey
Englewood, New Jersey, United States, 07601
Sewell, New Jersey, United States, 08080
Westampton, New Jersey, United States, 08060
United States, New York
Albany, New York, United States, 12206
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Winston-Salem, North Carolina, United States, 27103
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
Mountlake Terrace, Washington, United States, 98043
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Lawrence A Hill, PharmD, MBA Watson Laboratories, Inc.
  More Information

No publications provided

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00919113     History of Changes
Other Study ID Numbers: UR08004
Study First Received: June 11, 2009
Results First Received: February 5, 2013
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Watson Pharmaceuticals:
Bladder Pain
GAG replacement therapy
IC/PBS

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Pain
Syndrome
Disease
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 20, 2014