Phase 2 N=33 Randomized Quadruple-blind Treatment

PK and Safety of SI-722 in IC/BPS

Interstitial Cystitis · Bladder Pain Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT04208087 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2023

Primary outcome: Primary: Maximum Plasma Concentration (Cmax) for SI-722 — NA; NA; NA; NA ng/mL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: SI-722 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Seikagaku Corporation
Primary completion: Jan 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Plasma Concentration (Cmax) for SI-722	NA; NA; NA; NA	—

Summary

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04208087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.