PK and Safety of SI-722 in IC/BPS

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Interstitial Cystitis, Bladder Pain Syndrome

In brief

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

Key facts

Study ID

NCT04208087

Run by

Seikagaku Corporation

People needed

33

Starts

2020-03-30

Expected to finish

2021-01-12

Last updated by the study team

2023-12-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Centex Studies — Houston, Texas, United States

Full record on ClinicalTrials.gov

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