PK and Safety of SI-722 in IC/BPS

• Status: Completed
• Trial end date: 2021-01-12
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seikagaku Corporation

Criteria

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