NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051210106

Registered date:13/10/2021

ESTOC study

Basic Information

Recruitment status Suspended
Health condition(s) or Problem(s) studiedInterstitial cystitis
Date of first enrollment13/10/2021
Target sample size100
Countries of recruitment
Study typeInterventional
Intervention(s)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.

Outcome(s)

Primary OutcomeChange of interstitial cystitis symptom scores
Secondary OutcomeA. 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.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaPatients diagnosed as IC
Exclude criteria1) 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

Related Information

Contact

Public contact
Name Kazumasa Torimoto
Address 840 Shijo-cho, Kashihara, Nara Nara Japan 634-8522
Telephone +81-744-22-3051
E-mail torimoto@naramed-u.ac.jp
Affiliation Nara Medical University Hospital
Scientific contact
Name Kazumasa Torimoto
Address 840 Shijo-cho, Kashihara, Nara Nara Japan 634-8522
Telephone +81-744-22-3051
E-mail torimoto@naramed-u.ac.jp
Affiliation Nara Medical University Hospital