PK and Safety of SI-722 in IC/BPS

Phase 1

Completed

• Conditions: Interstitial Cystitis; Bladder Pain Syndrome
• Interventions: Drug: Placebo; Drug: SI-722

• Registration Number: NCT04208087
• Lead Sponsor: Seikagaku Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-12-18
• Study First Posted: 2019-12-23
• Study Start: 2020-03-30
• Primary Completion: 2021-01-12
• Study Completion: 2021-01-12
• Disposition First Submitted: 2021-12-10
• Disposition First Submitted QC: 2021-12-15
• Disposition First Posted: 2021-12-20
• Status Verified: 2023-12
• Results First Submitted: 2023-12-10
• Results First Submitted QC: 2023-12-10
• Last Update Submitted: 2023-12-10
• Results First Posted: 2023-12-29
• Last Update Posted: 2023-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
SI-722	SI-722	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

TriValley Urology Medical Group; 🇺🇸 Murrieta, California, United States

Premier Medical Associates; 🇺🇸 The Villages, Florida, United States

American Institute of Research; 🇺🇸 Los Angeles, California, United States

Centex Studies; 🇺🇸 Houston, Texas, United States

AccuMed Research Associates; 🇺🇸 Garden City, New York, United States