ESTOC study

The Effect of Suplatast Tosilate for interstitial Cystitis: A randomized controlled open-label trial - ESTOC study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051210106

Enrollment

100

Registered

2021-10-13

Start date

2021-10-13

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 bladder, inflammation, pain

Interventions

Participants will be randomly assigned to splatast group or control group. In splatast group, splatast tosilate capsule 100 mg (1 capsule at a time) will be orally administered 3 times a day between m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients diagnosed as IC

Exclusion criteria

Exclusion criteria: 1) Patients who are allergic to the treatment drug 2) Patients with serious liver disease (AST (GOT) or ALT (GPT) 100 IU / L or higher) 3) Patients who are pregnant or may become pregnant 4) Patients who took the study drug within 3 months before the start of study drug administration 5) Patients who are judged to be inappropriate as subjects by the investigator

Design outcomes

Primary

Measure	Time frame
Change of interstitial cystitis symptom scores	—

Secondary

Measure	Time frame
A. 1. Change of interstitial cystitis problem score 2. Frequency volume charts for two days will offer chage of mean 24-h urinary frequency, change of mean voided volume. 3. Urinanalysis will offer change of number of white blood cells and red blood cells per high power field. 4. Safty will conclude subjective symptoms, etc. B. Participants will be divided at a cut-off value of 28.4 micro-g / mL for serum 1-linolenoylglycrophosphocholine concentration. The following items will be compared between the groups in each subgroup. The items will be change of interstitial cystitis symptom scores, change of interstitial cystitis problem scores, change of mean 24-h urinary frequency, and change of mean voided volume. C. Participants will be divided at a cut-off value of 75 percentile for serum anandamide concentration. The following items will be compared between the groups in each subgroup. The items will be change of interstitial cystitis symptom scores, change of interstitial cystitis problem scores, change of mean 24-h urinary frequency, and change of mean voided volume.	—

Measure

Time frame

A. 1. Change of interstitial cystitis problem score 2. Frequency volume charts for two days will offer chage of mean 24-h urinary frequency, change of mean voided volume. 3. Urinanalysis will offer change of number of white blood cells and red blood cells per high power field. 4. Safty will conclude subjective symptoms, etc. B. Participants will be divided at a cut-off value of 28.4 micro-g / mL for serum 1-linolenoylglycrophosphocholine concentration. The following items will be compared between the groups in each subgroup. The items will be change of interstitial cystitis symptom scores, change of interstitial cystitis problem scores, change of mean 24-h urinary frequency, and change of mean voided volume. C. Participants will be divided at a cut-off value of 75 percentile for serum anandamide concentration. The following items will be compared between the groups in each subgroup. The items will be change of interstitial cystitis symptom scores, change of interstitial cystitis problem scores, change of mean 24-h urinary frequency, and change of mean voided volume.

—

Contacts

Public ContactKazumasa Torimoto

Nara Medical University Hospital

torimoto@naramed-u.ac.jp+81-744-22-3051

Outcome results

None listed

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