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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 8 weekly bladder instillations of Uracyst | Experimental | 20 mL Uracyst (2% sodium chondroitin sulfate) per instillation; 8 instillations over a 7-week period |
|
| 8 weekly bladder instillations of inactive control | Placebo Comparator | 20 mL inactive control buffer (phosphate-buffered saline); 8 instillations over a 7-week period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% sodium chondroitin sulfate | Drug | Weekly 20 mL Intravesical instillation |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence A Hill, PharmD, MBA | Watson Laboratories, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boulder | Colorado | 80304 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Uracyst | 2% sodium chondroitin sulfate |
| FG001 | Placebo | identical buffer |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | The identical buffer used in Uracyst for the same administration |
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| Denver |
| Colorado |
| 80211 |
| United States |
| Farmington | Connecticut | 06032 | United States |
| Plantation | Florida | 33317 | United States |
| Wellington | Florida | 33414 | United States |
| Columbus | Georgia | 31904 | United States |
| Coeur d'Alene | Idaho | 83814 | United States |
| Evanston | Illinois | 60201 | United States |
| Melrose Park | Illinois | 60160 | United States |
| Royal Oak | Michigan | 48073 | United States |
| Las Vegas | Nevada | 89148 | United States |
| Englewood | New Jersey | 07601 | United States |
| Sewell | New Jersey | 08080 | United States |
| Woodlane | New Jersey | 08060 | United States |
| Albany | New York | 12206 | United States |
| Poughkeepsie | New York | 12601 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Oklahoma City | Oklahoma | 73104 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Mountlake Terrace | Washington | 98043 | United States |
| Received Uracyst |
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| Received Placebo |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Uracyst | 2% sodium chondroitin sulfate |
| BG001 | Placebo | identical buffer |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Global Response Assessment (GRA) Responders at Week 11. | subjects that indicated "markedly improved" or "moderately improved" on the GRA, LOCF | Efficacy analysis performed according to randomized treatment. | Posted | Number | participants | at week 11 |
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| 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 | Efficacy analysis performed according to randomized treatment. | Posted | Number | participants | at week 11 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Uracyst | 2% sodium chondroitin sulfate One subject was misrandomized. Actual treatment was used for Demographic and Safety analysis. | 1 | 49 | 21 | 49 | ||
| EG001 | Placebo | identical buffer One subject was misrandomized. Actual treatment was used for Demographic and Safety analysis. | 2 | 49 | 18 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rectal Haemorrhage | Gastrointestinal disorders |
| |||
| Colitis | Gastrointestinal disorders |
| |||
| Suicidal Ideation | Psychiatric disorders |
| |||
| Angina Pectoris | Cardiac disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Respiratory, thoracic and mediastinal disorders |
| |||
| Dysuria | Renal and urinary disorders |
| |||
| Headache | Psychiatric disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Cystitis Interstitial | Renal and urinary disorders |
| |||
| Urinary Tract Infection | Renal and urinary disorders |
| |||
| Bladder Pain | Renal and urinary disorders |
| |||
| Constipation | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Hoel, RPh PhD, VP Global Brands Clinical Research | Watson Laboratories, Inc. | 801 588-6641 | gary.hoel@watson.com |
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D002809 | Chondroitin Sulfates |
| D002021 | Buffers |
| ID | Term |
|---|---|
| D002807 | Chondroitin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D019995 | Laboratory Chemicals |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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| >=65 years |
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| Male |
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