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Completed

NCT Number: NCT02637960

Efficacy Study of Fedovapagon for Nocturia in Men With Benign Prostatic Hyperplasia (BPH)

This study will investigate the efficacy and safety of fedovapagon in the treatment of nocturia in men with BPH.

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Key information

Conditions

Nocturia Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Vantia Investigative Center, Anniston, Alabama, United States

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About this study

Fedovapagon is a selective vasopressin V2 receptor (V2R) agonist that has an antidiuretic effect through stimulation of V2 receptors in the kidney and is being developed for the treatment of nocturia. Nocturia, defined as the complaint that the individual has to wake at night one or more times to void, is a common condition and shows an age-dependent increase in both prevalence and severity (number of nocturnal voids). It has a significant detrimental impact on the quality of life in patients with benign prostatic hyperplasia (BPH).

The purpose of this study is to determine the efficacy and safety of fedovapagon in the treatment of nocturia with BPH.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult males ≥18 years [no upper limit]
  • Benign prostatic hyperplasia
  • Persistent nocturia despite previous lifestyle modification advice including appropriate fluid management
  • Serum sodium not below lower limit of normal prior to randomization
  • Provide signed and dated informed consent before any study-specific procedures are conducted.
  • Able to comply with the requirements of the study.

Exclusion criteria

-

Treatment and study plan

Fedovapagon 2 mg

Drug

One daily dose of 2 mg fedovapagon for 12 weeks

Placebo

Drug

One daily dose of placebo (matched to fedovapagon) for 12 weeks

Primary outcomes

  1. Change in the mean number of night-time voids

    Time frame: 12 weeks

  2. Change in mean patient reported nocturia bother score

    Time frame: 12 weeks

Secondary outcomes

  1. Change in the mean number of night-time voids

    Time frame: 1 week

  2. Change in the mean number of night-time voids

    Time frame: 4 weeks

  3. Change in mean patient reported nocturia bother score

    Time frame: 1 week

  4. Change in mean patient reported nocturia bother score

    Time frame: 4 weeks

  5. Change in mean night-time urine production, absolute and as a proportion of 24 hour urine production

    Time frame: 2 months

  6. Change in mean functional bladder capacity

    Time frame: 2 months

  7. Change in International Prostate Symptom Score (IPSS)

    Time frame: 4 weeks

  8. Change in International Prostate Symptom Score (IPSS)

    Time frame: 12 weeks

  9. Change in N-QOL Score

    Time frame: 4 weeks

  10. Change in N-QOL Score

    Time frame: 12 weeks

  11. Number and type of Adverse Events

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Vantia Ltd

Industry

Registry information

Official study title

A Randomised, Double-blind, Placebo-controlled, Multi-centre Study to Investigate the Efficacy and Safety of Fedovapagon in the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia (BPH) (EQUINOC Study)

Acronym: EQUINOC

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 22, 2015
Registry last updated
Oct 31, 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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