PK and Safety of SI-722 in IC/BPS

Phase 2CompletedNCT04208087

Seikagaku Corporation33 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Interstitial Cystitis Bladder Pain Syndrome

Interventions

SI-722DRUG

SI-722 will be intravesically instilled.

PlaceboDRUG

Placebo will be intravesically instilled.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (5)

American Institute of Research

Los Angeles, California, United States

TriValley Urology Medical Group

Murrieta, California, United States

Premier Medical Associates

The Villages, Florida, United States

AccuMed Research Associates

Garden City, New York, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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