Study of efficacy of alpha1AR inhibitors for FBD

Phase 2

Recruiting

• Conditions: Functional bowel disease; D043183

• Registration Number: JPRN-jRCTs041200057
• Lead Sponsor: Tsunaki Sawada

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 135

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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,