Efficacy and Safety Study of Uracyst to Treat Interstitial Cystitis/Painful Bladder Syndrome - Full Text View

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:

MedlinePlus related topics: Interstitial Cystitis

Drug Information available for: Sulfate ion

U.S. FDA Resources

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

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
Pain
Cystitis, Interstitial
Urinary Bladder Diseases

Urologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013