Bladder Pain Syndrome, Interstitial Cystitis
Conditions
Keywords
Bladder, Intravesical Injection, Interstitial Cystitis
Brief summary
This study is designed randomized, double-blind, placebo-controlled trial in Interstitial Cystitis/Bladder Pain Syndrome patients.
Interventions
DRUGSI-722
SI-722 will be intravesically instilled.
DRUGPlacebo
Placebo will be intravesically instilled.
Sponsors
Seikagaku Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Males or females, ≥18 and ≤80 years of age * A score of 19 or greater on the Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS)
Exclusion criteria
* Urinary tract infection ≤30 days * Treatment with intravesical therapy ≤60 days * Treatment with any opioid therapy ≤7 days * History of bladder hydrodistension ≤3 months * Has cancer or a past history of any cancer ≤5 years * Body mass index (BMI) ≥40 kg/m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) for SI-722 | 4 weeks | SI-722 concentrations in plasma were measured using collected blood samples, and plasma PK parameters for SI-722 were estimated. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo The participants received a single intravesical instillation of Placebo | 8 |
| Low Dose of SI-722 The participants received a single intravesical instillation of Low Dose of SI-722 | 6 |
| Medium Dose of SI-722 The participants received a single intravesical instillation of Medium Dose of SI-722 | 6 |
| Medium-high Dose of SI-722 The participants received a single intravesical instillation of Medium-high Dose of SI-722 | 6 |
| High Dose of SI-722 The participants received a single intravesical instillation of High Dose of SI-722 | 7 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Other | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Low Dose of SI-722 | Medium Dose of SI-722 | Medium-high Dose of SI-722 | High Dose of SI-722 | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 55.6 years STANDARD_DEVIATION 16.15 | 41.8 years STANDARD_DEVIATION 6.4 | 51.0 years STANDARD_DEVIATION 14.91 | 54.0 years STANDARD_DEVIATION 17.79 | 45.4 years STANDARD_DEVIATION 11.47 | 49.8 years STANDARD_DEVIATION 14.16 |
| Body Mass Index | 27.13 kilograms/meter square STANDARD_DEVIATION 5.79 | 32.52 kilograms/meter square STANDARD_DEVIATION 4.37 | 26.20 kilograms/meter square STANDARD_DEVIATION 3.23 | 23.63 kilograms/meter square STANDARD_DEVIATION 3.39 | 28.59 kilograms/meter square STANDARD_DEVIATION 6.01 | 27.61 kilograms/meter square STANDARD_DEVIATION 5.35 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 3 Participants | 1 Participants | 1 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 1 Participants | 3 Participants | 5 Participants | 6 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 5 Participants | 5 Participants | 6 Participants | 5 Participants | 27 Participants |
| Sex: Female, Male Female | 6 Participants | 3 Participants | 5 Participants | 4 Participants | 7 Participants | 25 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 1 Participants | 2 Participants | 0 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 4 / 8 | 1 / 6 | 1 / 6 | 3 / 6 | 3 / 6 |
| serious Total, serious adverse events | 0 / 8 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
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.
Time frame: 4 weeks
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Dose of SI-722 | Maximum Plasma Concentration (Cmax) for SI-722 | NA ng/mL |
| Medium Dose of SI-722 | Maximum Plasma Concentration (Cmax) for SI-722 | NA ng/mL |
| Medium-high Dose of SI-722 | Maximum Plasma Concentration (Cmax) for SI-722 | NA ng/mL |
| High Dose of SI-722 | Maximum Plasma Concentration (Cmax) for SI-722 | NA ng/mL |