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Completed

NCT Number: NCT03116191

Trial of SK-1404 for Nocturia Due to Nocturnal Polyuria in Japanese Subjects

The purpose of this trial is to demonstrate efficacy of SK-1404 against placebo for the treatment of subjects with nocturia due to nocturnal polyuria, during 4 weeks of treatment.

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Key information

Conditions

Nocturia Due to Nocturnal Polyuria

Age range

55 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational site (there may be other sites in this country)

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 5 > nocturnal voids ≥2
  • NPI >0.33

Exclusion criteria

  • Polydipsia
  • Cardiac failure
  • Syndrome of inappropriate antidiuretic hormone secretion
  • Hyponatraemia
  • Uncontrolled diabetes mellitus
  • Uncontrolled hypertension
  • Moderate or severe over-active bladder (OAB)
  • Severe benign prostate hyperplasia (BPH)
  • Sleep apnoea
  • Interstitial cystitis
  • Stress urinary incontinence
  • Diabetes insipidus
  • Complication or a history of urological cancer

Treatment and study plan

SK-1404

Drug

4 weeks of repeated administration of SK-1404 to the patients of nocturia

Placebo

Drug

4 weeks of repeated administration of Placebo to the patients of nocturia

Primary outcomes

  1. Change from baseline in mean number of nocturnal voids

    Time frame: 4 weeks

    Assessed by the voiding diary

Secondary outcomes

  1. Change from base line in mean nocturnal urine volume

    Time frame: 4 weeks

    Assessed by the voiding diary

  2. Change from base line in mean time to first awakening to void

    Time frame: 4 weeks

    Assessed by the voiding diary

  3. Change from base line in mean Nocturnal Polyuria Index (NPI)

    Time frame: 4 weeks

    Assessed by the voiding diary

  4. Change from base line in the score of Nocturia-Specific Quality-of-Life Questionnaire (N-QoL)

    Time frame: 4 weeks

    Assessed by the voiding diary

Sponsors and collaborators

Lead sponsor

Sanwa Kagaku Kenkyusho Co., Ltd.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 14, 2017
Registry last updated
Apr 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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