PK and Safety of SI-722 in IC/BPS
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
1 other identifier
interventional
33
1 country
5
Brief Summary
This study is designed randomized, double-blind, placebo-controlled trial in Interstitial Cystitis/Bladder Pain Syndrome patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2020
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2019
CompletedFirst Posted
Study publicly available on registry
December 23, 2019
CompletedStudy Start
First participant enrolled
March 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 12, 2021
CompletedResults Posted
Study results publicly available
December 29, 2023
CompletedDecember 29, 2023
December 1, 2023
10 months
November 25, 2019
December 10, 2023
December 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
SI-722
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
American Institute of Research
Los Angeles, California, 90017, United States
TriValley Urology Medical Group
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development Dept.
- Organization
- Seikagaku Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2019
First Posted
December 23, 2019
Study Start
March 30, 2020
Primary Completion
January 12, 2021
Study Completion
January 12, 2021
Last Updated
December 29, 2023
Results First Posted
December 29, 2023
Record last verified: 2023-12