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This study is designed randomized, double-blind, placebo-controlled trial in Interstitial Cystitis/Bladder Pain Syndrome patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SI-722 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SI-722 | Drug | SI-722 will be intravesically instilled. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) for SI-722 | SI-722 concentrations in plasma were measured using collected blood samples, and plasma PK parameters for SI-722 were estimated. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Institute of Research | Los Angeles | California | 90017 | United States | ||
| TriValley Urology Medical Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | The participants received a single intravesical instillation of Placebo |
| FG001 | Low Dose of SI-722 | The participants received a single intravesical instillation of Low Dose of SI-722 |
| FG002 | Medium Dose of SI-722 | The participants received a single intravesical instillation of Medium Dose of SI-722 |
| FG003 | Medium-high Dose of SI-722 | The participants received a single intravesical instillation of Medium-high Dose of SI-722 |
| FG004 | High Dose of SI-722 | The participants received a single intravesical instillation of High Dose of SI-722 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | The participants received a single intravesical instillation of Placebo |
| BG001 | Low Dose of SI-722 | The participants received a single intravesical instillation of Low Dose of SI-722 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Maximum Plasma Concentration (Cmax) for SI-722 | SI-722 concentrations in plasma were measured using collected blood samples, and plasma PK parameters for SI-722 were estimated. | The PK Population is defined as all subjects who received SI-722 and who provided at least 1 evaluable PK sample. One participant in the High Dose group was excluded from PK population because the subject discontinued before IP administration due to difficulty with drawing blood. | Posted | Mean | Standard Deviation | ng/mL | 4 weeks |
|
4 weeks
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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 | Placebo | The participants received a single intravesical instillation of Placebo |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Dept. | Seikagaku Corporation | (81)3-5220-8593 | 722_clinical_project_team@seikagaku.co.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2020 | Dec 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Drug |
Placebo will be intravesically instilled. |
|
| Murrieta |
| California |
| 92562 |
| United States |
| Premier Medical Associates | The Villages | Florida | 32159 | United States |
| AccuMed Research Associates | Garden City | New York | 11530 | United States |
| Centex Studies | Houston | Texas | 77058 | United States |
| Withdrawal by Subject |
|
| Other |
|
| BG002 | Medium Dose of SI-722 | The participants received a single intravesical instillation of Medium Dose of SI-722 |
| BG003 | Medium-high Dose of SI-722 | The participants received a single intravesical instillation of Medium-high Dose of SI-722 |
| BG004 | High Dose of SI-722 | The participants received a single intravesical instillation of High Dose of SI-722 |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kilograms/meter square |
|
The participants received a single intravesical instillation of Medium Dose of SI-722
| OG002 | Medium-high Dose of SI-722 | The participants received a single intravesical instillation of Medium-high Dose of SI-722 |
| OG003 | High Dose of SI-722 | The participants received a single intravesical instillation of High Dose of SI-722 |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 4 |
| 8 |
| EG001 | Low Dose of SI-722 | The participants received a single intravesical instillation of Low Dose of SI-722 | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | Medium Dose of SI-722 | The participants received a single intravesical instillation of Medium Dose of SI-722 | 0 | 6 | 0 | 6 | 1 | 6 |
| EG003 | Medium-high Dose of SI-722 | The participants received a single intravesical instillation of Medium-high Dose of SI-722 | 0 | 6 | 0 | 6 | 3 | 6 |
| EG004 | High Dose of SI-722 | The participants received a single intravesical instillation of High Dose of SI-722 | 0 | 6 | 0 | 6 | 3 | 6 |
| Genital herpes | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | Systematic Assessment |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |