Dose Range Finding Study of Fedovapagon in Men With Nocturia

A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Dose Range Finding Study To Determine The Efficacy And Safety Of Fedovapagon In Men With Nocturia

The purpose of this study is to determine the dose level(s) of fedovapagon which result in a decrease in the mean nocturnal void frequency.

Study Overview

• Status: Completed
• Conditions: Nocturia
• Intervention / Treatment: Drug: fedovapagon 1 mg; Drug: fedovapagon 2 mg; Drug: fedovapagon 4 mg; Drug: Placebo ( sugar pill)

Detailed Description

Fedovapagon is a selective vasopressin V2 receptor (V2 receptor) agonist that is being developed for the treatment of Nocturia.

The antidiuretic effect of V2 receptor stimulation in the kidneys is well established through the use of the peptide agonist, desmopressin, which shows clinical benefit in diabetes insipidus, primary nocturnal enuresis and Nocturia.

Nocturia, defined as the complaint that the individual has to wake at night one or more times to void, is a common complaint and shows an age-dependent increase in both prevalence and severity (number of Nocturnal Voids). It is the most bothersome symptom of benign prostatic hypertrophy (BPH) and has been linked to an age-dependent loss in circadian release of endogenous nocturnal vasopressin and consequent over production of urine at night (Nocturnal Polyuria).

The purpose of this Phase IIb study is to determine the efficacy of different doses of fedovapagon in reducing the number of times subjects with Nocturia void during the night together with other parameters including increasing the time between going to bed and waking to first void. By establishing the effective doses of fedovapagon on these clinical endpoints, the data from this study will determine the most appropriate dose(s) of fedovapagon for the treatment of Nocturia to be taken forward into further studies.

• Study Type: Interventional
• Enrollment (Actual): 358
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
      • Vantia Investigative Center
    • Huntsville, Alabama, United States
      • Vantia Investigative Center
    • Mobile, Alabama, United States
      • Vantia Investigative Center
  • Arizona
    • Glendale, Arizona, United States
      • Vantia Investigative Center
    • Tucson, Arizona, United States
      • Vantia Investigative Center
  • California
    • Anaheim, California, United States
      • Vantia Investigative Center
    • Long Beach, California, United States
      • Vantia Investigative Center
    • San Diego, California, United States
      • Vantia Investigative Center
  • Colorado
    • Denver, Colorado, United States
      • Vantia Investigative Center
    • Englewood, Colorado, United States
      • Vantia Investigative Center
  • Connecticut
    • Milford, Connecticut, United States
      • Vantia Investigative Center
  • Florida
    • Aventura, Florida, United States
      • Vantia Investigative Center
    • Clearwater, Florida, United States
      • Vantia Investigative Center
    • Daytona Beach, Florida, United States
      • Vantia Investigative Center
    • DeLand, Florida, United States
      • Vantia Investigative Center
    • Naples, Florida, United States
      • Vantia Investigative Center
    • Ocala, Florida, United States
      • Vantia Investigative Center
    • St. Petersburg, Florida, United States
      • Vantia Investigative Center
    • Tampa, Florida, United States
      • Vantia Investigative Center
  • Idaho
    • Coeur d'Alene, Idaho, United States
      • Vantia Investigative Center
    • Meridian, Idaho, United States
      • Vantia Investigative Center
  • Illinois
    • Chicago, Illinois, United States
      • Vantia Investigative Center
  • Indiana
    • Evansville, Indiana, United States
      • Vantia Investigative Center
    • Jeffersonville, Indiana, United States
      • Vantia Investigative Center
  • Kentucky
    • Paducah, Kentucky, United States
      • Vantia Investigative Center
  • Louisiana
    • Metairie, Louisiana, United States
      • Vantia Investigative Center
  • Maryland
    • Greenbelt, Maryland, United States
      • Vantia Investigative Center
  • Michigan
    • Rochester, Michigan, United States
      • Vantia Investigative Center
  • Minnesota
    • Edina, Minnesota, United States
      • Vantia Investigative Center
  • Nebraska
    • Omaha, Nebraska, United States
      • Vantia Investigative Center
  • New Jersey
    • Brick, New Jersey, United States
      • Vantia Investigative Center
    • Englewood, New Jersey, United States
      • Vantia Investigative Center
    • Lawrenceville, New Jersey, United States
      • Vantia Investigative Center
  • New Mexico
    • Albuquerque, New Mexico, United States
      • Vantia Investigative Center
  • New York
    • Brooklyn, New York, United States
      • Vantia Investigative Center
    • Endwell, New York, United States
      • Vantia Investigative Center
    • Garden City, New York, United States
      • Vantia Investigative Center
    • New York, New York, United States
      • Vantia Investigative Center
    • Poughkeepsie, New York, United States
      • Vantia Investigative Center
  • North Carolina
    • Concord, North Carolina, United States
      • Vantia Investigative Center
    • Raleigh, North Carolina, United States
      • Vantia Investigative Center
    • Winston Salem, North Carolina, United States
      • Vantia Investigative Center
  • Ohio
    • Cincinnati, Ohio, United States
      • Vantia Investigative Center
  • Oklahoma
    • Bethany, Oklahoma, United States
      • Vantia Investigative Center
  • Pennsylvania
    • Bala Cynwyd, Pennsylvania, United States
      • Vantia Investigative Center
  • Rhode Island
    • Warwick, Rhode Island, United States
      • Vantia Investigative Center
  • South Carolina
    • Mytrle Beach, South Carolina, United States
      • Vantia Investigative Center
  • South Dakota
    • Dakota Dunes, South Dakota, United States
      • Vantia Investigative Center
  • Tennessee
    • Nashville, Tennessee, United States
      • Vantia Investigative Center
  • Texas
    • Dallas, Texas, United States
      • Vantia Investigative Center
    • Fort Worth, Texas, United States
      • Vantia Investigative Center
    • San Antonio, Texas, United States
      • Vantia Investigative Center
  • Virginia
    • Richmond, Virginia, United States
      • Vantia Investigative Center
    • Virginia Beach, Virginia, United States
      • Vantia Investigative Center
  • Washington
    • Burien, Washington, United States
      • Vantia Investigative Center
  • Wisconsin
    • Middleton, Wisconsin, United States
      • Vantia Investigative Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Males aged 55 or over
• History and/ or symptoms of Nocturia (2 - 5 voids per night)
• Generally well (concomitant illness / conditions well controlled)
• Serum sodium, potassium, chloride and bicarbonate within normal limits
• No clinically significant abnormalities in other laboratory parameters, urinalysis, electrocardiogram (ECG) or physical examination
• Prostate specific antigen (PSA) within the normal range or not considered clinically significant
• Ability to comply with the requirements of the study
• Written informed consent.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fedovapagon 1 mg; Once daily oral dose of 1 mg fedovapagon for 12 weeks	Drug: fedovapagon 1 mg
Experimental: fedovapagon 2 mg; Once daily oral dose of 2 mg fedovapagon for 12 weeks	Drug: fedovapagon 2 mg
Experimental: fedovapagon 4 mg; Once daily oral dose of 4 mg fedovapagon for 12 weeks	Drug: fedovapagon 4 mg
Placebo Comparator: sugar pill; Once daily oral dose of placebo for 12 weeks	Drug: Placebo ( sugar pill)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in the mean nocturnal urine voids	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in the mean nocturnal urine voids	4 weeks
Change in the mean time to first nocturnal void	4 weeks
Change in the mean time to first nocturnal void	12 weeks
Change in Nocturia-related quality of life (N-QOL)	4 weeks
Change in Nocturia-related quality of life (N-QOL)	12 weeks

Collaborators and Investigators

• Sponsor: Vantia Ltd
• Investigators: Study Director: Hilary McElwaine-Johnn, BSc, ASM, MBBS, MRCP, MFPM, Vantia Ltd

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: July 31, 2012
• First Submitted That Met QC Criteria: August 1, 2012
• First Posted (Estimate): August 2, 2012

Study Record Updates

• Last Update Posted (Estimate): June 20, 2014
• Last Update Submitted That Met QC Criteria: June 18, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: VA106483, fedovapagon, Nocturia, males, nocturnal voids, anti-diuretic
• Additional Relevant MeSH Terms: Lower Urinary Tract Symptoms; Urological Manifestations; Nocturia
• Other Study ID Numbers: 483-009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No