Phase III study of KRP-116D

A Phase III, multicenter, randomized, double-blind, placebo controlled, parallel group study to assess the efficacy and safety of KRP-116D in Japanese patients with interstitial cystisis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223511

Enrollment

Registered

2017-04-20

Start date

2017-05-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial cystitis( IC )

Interventions

investigational material(s) Generic name etc : KRP-116D INN of investigational material : dimethyl sulfoxide Therapeutic category code : 259 Other agents for uro-genital and anal organ Dosage and Admi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosed with IC

Exclusion criteria

Exclusion criteria: Patients has complication or past history within 5 years with cancer Patients complicated with urinary tract/genital infection Patients has past history with augmentation cystoplasty or cystectomy

Design outcomes

Primary

Measure	Time frame
safety efficacy Efficacy(O'Leary and Sant's IC symptom index) Questionnaire	—

Secondary

Measure	Time frame
safety efficacy Efficacy(O'Leary and Sant's IC problem index, urinary symptom, bladder pain score,etc.), Safety Questionnaire, Symptom dairy, Adverse event and adverse drug reaction	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026