CompletedPhase 1/2

PK and Safety of SI-722 in IC/BPS

United States33 participantsStarted 2020-03-30

Plain-language summary

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

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Maximum Plasma Concentration (Cmax) for SI-722

Timeframe: 4 weeks

Trial details

NCT IDNCT04208087

SponsorSeikagaku Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-01-12

Results submitted2023-12-10

View on ClinicalTrials.gov More Interstitial Cystitis trials