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

Primary Purpose

Interstitial Cystitis, Painful Bladder Syndrome

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

2% sodium chondroitin sulfate

Placebo

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring Bladder Pain, GAG replacement therapy, IC/PBS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

8 weekly bladder instillations of Uracyst

8 weekly bladder instillations of inactive control

Arm Description

20 mL Uracyst (2% sodium chondroitin sulfate) per instillation; 8 instillations over a 7-week period

20 mL inactive control buffer (phosphate-buffered saline); 8 instillations over a 7-week period

Outcomes

Primary Outcome Measures

Global Response Assessment (GRA) Responders at Week 11.

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00919113

First Posted

June 11, 2009

Last Updated

May 1, 2013

Sponsor

Watson Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00919113

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Watson Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Interstitial Cystitis, Painful Bladder Syndrome

Keywords

Bladder Pain, GAG replacement therapy, IC/PBS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

98 (Actual)

8. Arms, Groups, and Interventions

Arm Title

8 weekly bladder instillations of Uracyst

Arm Type

Experimental

Arm Description

20 mL Uracyst (2% sodium chondroitin sulfate) per instillation; 8 instillations over a 7-week period

Arm Title

8 weekly bladder instillations of inactive control

Arm Type

Placebo Comparator

Arm Description

20 mL inactive control buffer (phosphate-buffered saline); 8 instillations over a 7-week period

Intervention Type

Drug

Intervention Name(s)

2% sodium chondroitin sulfate

Other Intervention Name(s)

Uracyst

Intervention Description

Weekly 20 mL Intravesical instillation

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

buffer

Intervention Description

The identical buffer used in Uracyst for the same administration

Primary Outcome Measure Information:

Title

Global Response Assessment (GRA) Responders at Week 11.

Description

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

Time Frame

at week 11

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

at week 11

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lawrence A Hill, PharmD, MBA

Organizational Affiliation

Watson Laboratories, Inc.

Official's Role

Study Director

Facility Information:

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80304

Country

United States

City

Denver

State/Province

Colorado

ZIP/Postal Code

80211

Country

United States

City

Farmington

State/Province

Connecticut

ZIP/Postal Code

06032

Country

United States

City

Plantation

State/Province

Florida

ZIP/Postal Code

33317

Country

United States

City

Wellington

State/Province

Florida

ZIP/Postal Code

33414

Country

United States

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

City

Coeur d'Alene

State/Province

Idaho

ZIP/Postal Code

83814

Country

United States

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

City

Melrose Park

State/Province

Illinois

ZIP/Postal Code

60160

Country

United States

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

City

Englewood

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

City

Sewell

State/Province

New Jersey

ZIP/Postal Code

08080

Country

United States

City

Westampton

State/Province

New Jersey

ZIP/Postal Code

08060

Country

United States

City

Albany

State/Province

New York

ZIP/Postal Code

12206

Country

United States

City

Poughkeepsie

State/Province

New York

ZIP/Postal Code

12601

Country

United States

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

City

Mountlake Terrace

State/Province

Washington

ZIP/Postal Code

98043

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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