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

ESTOC study (ESTOC study)

9

Male/Female: 1/8 Age 72.0 (61.5, 80.5) years Interstitial cystitis symptom index 6.0 (3.5, 8.0) Interstitial cystitie problem index 5.0 (0.0, 6.0) Values were expressed as median (interquartile range).

Participants were enrolled at Ueda Clinic between January 2023 and June 2023. The first case was enrolled on January 6, 2023. Selection of participants and obtaining their consent were more difficult than anticipated. Therefore, it was determined that it would be impossible to achieve the target of 100 participants.

There were no adverse events or other problems at all.

The study was terminated and no data analysis was performed.

Selection of participants and obtaining their consent were more difficult than anticipated. Therefore, it was determined that it would be impossible to achieve the target of 100 participants and the study was terminated.

Dec. 02, 2024

No

Not applicable.

https://jrct.mhlw.go.jp/latest-detail/jRCTs051210106

Torimoto Kazumasa

Nara Medical University Hospital

840 Shijo-cho, Kashihara, Nara

torimoto@naramed-u.ac.jp

Torimoto Kazumasa

Nara Medical University Hospital

840 Shijo-cho, Kashihara, Nara

+81-744-22-3051

torimoto@naramed-u.ac.jp

Complete

Oct. 13, 2021

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

Patients diagnosed as IC

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

Both

Interstitial cystitis

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 meals for 3 months. In control group, flavoxate hydrochloride tablets 200 mg (1 tablet at a time) will be orally administered 3 times a day between meals for 3 months.

bladder, inflammation, pain

D018856

Change of interstitial cystitis symptom scores

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.

+81-744-29-8835

Sept. 29, 2021

None