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| ID | Type | Description | Link |
|---|---|---|---|
| B2381036 | Other Identifier | Pfizer |
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This is a multicenter, randomized, double-blind, placebo-controlled, parallel-design, exploratory study of orally administered ERB-041 in subjects with active IC. The primary objectives of this study will be to investigate ERB-041's activity on levels of urinary APF, explore the gene expression response in peripheral blood mononuclear cells (PBMC), and to evaluate the safety of ERB-041 in women with active IC.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERB-041 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | ||
| Levels of urinary antiproliferative factor (APF) | ||
| Peripheral blood mononuclear cell (PBMC) gene expression profiles |
| Measure | Description | Time Frame |
|---|---|---|
| Serum and urinary biomarkers of IC | ||
| Clinical Activity: | ||
| Global Response Assessment (GRA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Monitor | For Germany, MedinfoDEU@wyeth.com | Principal Investigator |
| Trial Manager | For Austria, WPVIMED@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendora | California | 91741 | United States | |||
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| O'Leary-Sant IC Symptom (ICSI) and Problem (ICPI) Index |
| Pelvic Pain and Urinary/Frequency (PUF) Symptom Scale |
| Female Sexual Function Index (FSFI) |
| Voiding Diary |
| Redding |
| California |
| 96001 |
| United States |
| San Diego | California | 92103 | United States |
| Aventura | Florida | 33180 | United States |
| Kansas City | Kansas | 66160 | United States |
| Jackson | Michigan | 49201 | United States |
| Springfield | Oregon | 97477 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Philadelphia | Pennsylvania | 19140 | United States |
| Philadelphia | Pennsylvania | 19146 | United States |
| Houston | Texas | 77030 | United States |
| Temple | Texas | 76508 | United States |
| Mountlake Terrace | Washington | 98043 | United States |
| Baden | A-2500 | Austria |
| Homburg/Saar | 66421 | Germany |
| Münster | 48149 | Germany |
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| D003556 | Cystitis |
| ID | Term |
|---|---|
| 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 |
|---|---|
| C478102 | ERB 041 |
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