Study of efficacy of alpha1AR inhibitors for FBD

JRCT ID: jRCTs041200057

Registered date:02/11/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Functional bowel disease
• Date of first enrollment: 02/11/2020
• Target sample size: 135
• Study type: Interventional

Intervention(s)

Silodosin 4mg Oral twice a day. 3 months.
Naftopidil 25mg Oral Once a day If the effect is insufficient, the dose can be increased up to 75mg. 3 months.

Outcome(s)

Primary Outcome

IBS group (IBS-D, IBS-C): Responder rate of the overall improvement effect of IBS symptoms.
FBD group (FD, FC): Responder rate of improving bowel movement

• Secondary Outcome: Defecation status improvement effect, abdominal pain / abdominal discomfort improvement effect, straining score, defaecation urgency score, abdominal pain score, SBM, number of stool, stool shape scale, QOL score, adverse events, abnormal laboratory values,

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

Patients who are diagnosed to Irritable Bowel Syndrome (IBS), Functional Constipation (FC), Functional Diarrhea (FD), Functional Bloating (FB), and Unclassified FBD ( Unspecified FBD: UFBD), in accordance with the Rome 4 criteria.
20 years old and under 75 years old. It doesn't matter gender.
In the case of females, only if there is no possibility of pregnancy in the interview, negative pregnancy reaction, and confirmation that no pregnancy has been attempted.
Pateints who understand and agree with the research.

Exclude criteria

Patients taking following medications (diuretics, azole antifungals, drugs with PGE5 inhibitory action).
Patients who are taking antihypertensive drugs and have a history of orthostatic hypotension
A case of internal treatment for benign prostatic hyperplasia.
Case after surgical treatment for the digestive tract.
Patients with liver function abnormalities (AST, ALT, gammaGT, ALP, LDH) are more than 1.5 times the facility standard value.(Those with already diagnosed mild liver dysfunction due to fatty liver or NASH can participate in the study.)
Other cases with serious complications or abnormal laboratory values.
Other cases where the investigator determines that participation in clinical studies is inappropriate.

Related Information

• Primary Sponsor: Tsunaki Sawada
• Source(s) of Monetary Support: ASKA Pharmaceutical Co., Ltd.