Back to resultsPK and Safety of SI-722 in IC/BPS
Primary Purpose
Interstitial Cystitis, Bladder Pain Syndrome
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SI-722
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Cystitis focused on measuring Bladder, Intravesical Injection, Interstitial Cystitis
Eligibility Criteria
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
Sites / Locations
- American Institute of Research
- TriValley Urology Medical Group
- Premier Medical Associates
- AccuMed Research Associates
- Centex Studies
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SI-722
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Maximum observed plasma concentration (Cmax)
To assess Cmax after single dose of SI-722
Time to reach the Maximum observed plasma concentration (Tmax)
To assess tmax after dose of SI-722
Cumulative amount of drug excreted in urine (Ae)
To assess Ae after dose of SI-722
Number of participants with treatment-related adverse events
To assess the incidence of treatment-related adverse events after dose of SI-722
Cystoscopy
To assess abnormal change from baseline in cystoscopy
Number of participants with clinical significant change in vital signs, electrocardiograms and clinical laboratory assessments
Number of participants with clinical significant change in vital signs, electrocardiograms and clinical laboratory assessments will be assessed.
Secondary Outcome Measures
Subject Diary
To assess change from baseline in bladder pain, symptoms, voiding frequency and voiding volume
Interstitial Cystitis Symptom Index Score/Problem Index Score
Interstitial Cystitis Symptom Index Score/Problem Index Score (ICSI/PI) will be used to assess the change from baseline of the symptoms of IC/BPS. ICSI and ICPI have 4-items respectively.
Regarding ICSI, each item on the questionnaire is scored from 0 to 5 and this means that a person can score between 0 and 20 for symptom of IC/BPS.
Regarding ICPI, each item on the questionnaire is scored from 0 to 4 and this means that a person can score between 0 and 16 for problem of IC/BPS.
These higher scores mean a worse outcome.
Bladder Pain/Interstitial Cystitis Symptom Score
Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS) will be used to assess change from baseline of the symptoms of IC/BPS.
Questions 1-7 are scored from 0-4, and question 8 is scored from 0-10. Using these 8 questions, person can score between 0 and 38. These higher scores mean a worse outcome.
Global Response Assessment
Global Response Assessment (GRA) will be used to assess change from baseline of the symptoms of IC/BPS.
This questionnaire includes 7 point scale which is centered at zero (no change): markedly worse; moderately worse; slightly worse; no change; slightly improved; moderately improved; and markedly improved.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04208087
Brief Title
PK and Safety of SI-722 in IC/BPS
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of SI-722 Intravesical Instillation in Interstitial Cystitis/Bladder Pain Syndrome Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 30, 2020 (Actual)
Primary Completion Date
January 12, 2021 (Actual)
Study Completion Date
January 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seikagaku Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed randomized, double-blind, placebo-controlled trial in Interstitial Cystitis/Bladder Pain Syndrome patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis, Bladder Pain Syndrome
Keywords
Bladder, Intravesical Injection, Interstitial Cystitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SI-722
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SI-722
Intervention Description
SI-722 will be intravesically instilled.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be intravesically instilled.
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax)
Description
To assess Cmax after single dose of SI-722
Time Frame
4 weeks
Title
Time to reach the Maximum observed plasma concentration (Tmax)
Description
To assess tmax after dose of SI-722
Time Frame
4 weeks
Title
Cumulative amount of drug excreted in urine (Ae)
Description
To assess Ae after dose of SI-722
Time Frame
4 weeks
Title
Number of participants with treatment-related adverse events
Description
To assess the incidence of treatment-related adverse events after dose of SI-722
Time Frame
4 weeks
Title
Cystoscopy
Description
To assess abnormal change from baseline in cystoscopy
Time Frame
4 weeks
Title
Number of participants with clinical significant change in vital signs, electrocardiograms and clinical laboratory assessments
Description
Number of participants with clinical significant change in vital signs, electrocardiograms and clinical laboratory assessments will be assessed.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Subject Diary
Description
To assess change from baseline in bladder pain, symptoms, voiding frequency and voiding volume
Time Frame
4 weeks
Title
Interstitial Cystitis Symptom Index Score/Problem Index Score
Description
Interstitial Cystitis Symptom Index Score/Problem Index Score (ICSI/PI) will be used to assess the change from baseline of the symptoms of IC/BPS. ICSI and ICPI have 4-items respectively.
Regarding ICSI, each item on the questionnaire is scored from 0 to 5 and this means that a person can score between 0 and 20 for symptom of IC/BPS.
Regarding ICPI, each item on the questionnaire is scored from 0 to 4 and this means that a person can score between 0 and 16 for problem of IC/BPS.
These higher scores mean a worse outcome.
Time Frame
4 weeks
Title
Bladder Pain/Interstitial Cystitis Symptom Score
Description
Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS) will be used to assess change from baseline of the symptoms of IC/BPS.
Questions 1-7 are scored from 0-4, and question 8 is scored from 0-10. Using these 8 questions, person can score between 0 and 38. These higher scores mean a worse outcome.
Time Frame
4 weeks
Title
Global Response Assessment
Description
Global Response Assessment (GRA) will be used to assess change from baseline of the symptoms of IC/BPS.
This questionnaire includes 7 point scale which is centered at zero (no change): markedly worse; moderately worse; slightly worse; no change; slightly improved; moderately improved; and markedly improved.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
American Institute of Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
TriValley Urology Medical Group
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Premier Medical Associates
City
The Villages
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Facility Name
AccuMed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Centex Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
12. IPD Sharing Statement
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PK and Safety of SI-722 in IC/BPS
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