Phase II study of KRP-N118 in patients with Nocturia due to nocturnal polyuria

A phase II randomized double blind placebo-controlled parallel-group multicenter study of KRP-N118 in patients with Nocturia due to nocturnal polyuria

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224041

Enrollment

880

Registered

2018-09-06

Start date

2018-09-18

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

Nocturia due to nocturnal polyuria.

Interventions

investigational material(s) Generic name etc : KRP-N118 INN of investigational material : - Therapeutic category code : 249 Other hormone preparations (including antihormone preparations) Dosage and A

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 2 or more nocturnal voids or less 5 Nocturnal polyuria

Exclusion criteria

Exclusion criteria: Complication or a history of cardiac failure Hyponatremia Uncontrolled diabetes mellitus Uncontrolled hypertension Severe benign prostate hyperplasia (BPH) Central or renal diabetes insipidus

Design outcomes

Primary

Measure	Time frame
safety efficacy Nocturnal voids Voiding diary	—

Secondary

Measure	Time frame
safety efficacy Nocturnal urine volume Voiding diary	—

Countries

Japan

Outcome results

None listed

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