ESTOC study

JRCT ID: jRCTs051210106

Registered date:13/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Interstitial cystitis
• Date of first enrollment: 13/10/2021
• Target sample size: 100
• Study type: Interventional

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 Outcome: Change of interstitial cystitis symptom scores

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients diagnosed as IC

Exclude 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

Related Information

• Primary Sponsor: Torimoto Kazumasa
• Secondary Sponsor: Fujimoto Kiyohide
• Source(s) of Monetary Support: Nara Medical University