Randomized controlled trials of additional ramelteon to alpha1-blockers for nocturia with sleep disorders.

Randomized controlled trials of additional ramelteon to alpha1-blockers for nocturia with sleep disorders. - Randomized controlled trials of additional ramelteon to alpha1-blockers for nocturia with sleep disorders.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006712

Enrollment

100

Registered

2011-11-12

Start date

2011-11-01

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

Benign prostatic hypertroplasia

Interventions

Sleep instruction Sleep instruction + Oral ramelteon 8mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Nocturia of 2 times or more 2) 20 years old and more 3) Although alpha1 blocker is used, there is frequent nocturia. 4) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Patient with drug allergy 2) Severe liver dysfunction 3) During administration of Fluvoxamine maleate 4) Acute urinary tract infection 5) Physician deems inappropriate

Design outcomes

Primary

Measure	Time frame
number of nocturia	—

Secondary

Measure	Time frame
IPSS, OABSS, N-QOL, PSQI, Safety	—

Countries

Japan

Contacts

Public ContactTakashi Kawahara

Yokohama city university school of medicine Department of urology

045-787-2800

Outcome results

None listed

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