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Study of efficacy of alpha1AR inhibitors for FBD

Study of Efficacy and safety of alpha1 sympathetic receptor inhibitors for functional bowel disorders

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041200057
Enrollment
135
Registered
2020-11-02
Start date
2020-11-02
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional bowel disease

Interventions

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.

Sponsors

Tsunaki Sawada
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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,

Contacts

Public ContactTsunaki Sawada

Nagoya univesity hospital

t.sawada@med.nagoya-u.ac.jp+81-527442172

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026