PK and Safety of SI-722 in IC/BPS

Seikagaku

Status and phase: Completed; Phase 2; Phase 1

Conditions: Interstitial Cystitis; Bladder Pain Syndrome

Treatments: Drug: SI-722; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04208087

722/1121

Details and patient eligibility

About

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

Enrollment: 33 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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33 participants in 2 patient groups, including a placebo group

SI-722

Experimental group

Treatment:

Drug: SI-722

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo