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PK and Safety of SI-722 in IC/BPS

NCT ID: NCT04208087

Last Updated: 2023-12-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-30

Study Completion Date

2021-01-12

Brief Summary

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

Detailed Description

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Conditions

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Interstitial Cystitis Bladder Pain Syndrome

Keywords

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Bladder Intravesical Injection Interstitial Cystitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SI-722

Group Type EXPERIMENTAL

SI-722

Intervention Type DRUG

SI-722 will be intravesically instilled.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be intravesically instilled.

Interventions

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SI-722

SI-722 will be intravesically instilled.

Intervention Type DRUG

Placebo

Placebo will be intravesically instilled.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seikagaku Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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American Institute of Research

Los Angeles, California, United States

Site Status

TriValley Urology Medical Group

Murrieta, California, United States

Site Status

Premier Medical Associates

The Villages, Florida, United States

Site Status

AccuMed Research Associates

Garden City, New York, United States

Site Status

Centex Studies

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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722/1121

Identifier Type: -

Identifier Source: org_study_id