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

This study is designed randomized, double-blind, placebo-controlled trial in Interstitial Cystitis/Bladder Pain Syndrome patients.

Study Overview

• Status: Completed
• Conditions: Interstitial Cystitis; Bladder Pain Syndrome
• Intervention / Treatment: Drug: SI-722; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90017
      • American Institute of Research
    • Murrieta, California, United States, 92562
      • TriValley Urology Medical Group
  • Florida
    • The Villages, Florida, United States, 32159
      • Premier Medical Associates
  • New York
    • Garden City, New York, United States, 11530
      • AccuMed Research Associates
  • Texas
    • Houston, Texas, United States, 77058
      • Centex Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo will be intravesically instilled.
Experimental: SI-722	Drug: SI-722; SI-722 will be intravesically instilled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Diary	To assess change from baseline in bladder pain, symptoms, voiding frequency and voiding volume	4 weeks
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.	4 weeks
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.	4 weeks
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.	4 weeks

Collaborators and Investigators

• Sponsor: Seikagaku Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2020
• Primary Completion (Actual): January 12, 2021
• Study Completion (Actual): January 12, 2021

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 10, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Bladder; Interstitial Cystitis; Intravesical Injection
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Syndrome; Cystitis; Cystitis, Interstitial
• Other Study ID Numbers: 722/1121

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No