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Dose Range Finding Study of Fedovapagon in Men With Nocturia

Primary Purpose

Nocturia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
fedovapagon 1 mg
fedovapagon 2 mg
fedovapagon 4 mg
Placebo ( sugar pill)
Sponsored by
Vantia Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturia focused on measuring VA106483, fedovapagon, Nocturia, males, nocturnal voids, anti-diuretic

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center
  • Vantia Investigative Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

fedovapagon 1 mg

fedovapagon 2 mg

fedovapagon 4 mg

sugar pill

Arm Description

Once daily oral dose of 1 mg fedovapagon for 12 weeks

Once daily oral dose of 2 mg fedovapagon for 12 weeks

Once daily oral dose of 4 mg fedovapagon for 12 weeks

Once daily oral dose of placebo for 12 weeks

Outcomes

Primary Outcome Measures

Change in the mean nocturnal urine voids

Secondary Outcome Measures

Change in the mean nocturnal urine voids
Change in the mean time to first nocturnal void
Change in the mean time to first nocturnal void
Change in Nocturia-related quality of life (N-QOL)
Change in Nocturia-related quality of life (N-QOL)

Full Information

First Posted
July 31, 2012
Last Updated
June 18, 2014
Sponsor
Vantia Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01656239
Brief Title
Dose Range Finding Study of Fedovapagon in Men With Nocturia
Official Title
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Dose Range Finding Study To Determine The Efficacy And Safety Of Fedovapagon In Men With Nocturia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vantia Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia
Keywords
VA106483, fedovapagon, Nocturia, males, nocturnal voids, anti-diuretic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
358 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fedovapagon 1 mg
Arm Type
Experimental
Arm Description
Once daily oral dose of 1 mg fedovapagon for 12 weeks
Arm Title
fedovapagon 2 mg
Arm Type
Experimental
Arm Description
Once daily oral dose of 2 mg fedovapagon for 12 weeks
Arm Title
fedovapagon 4 mg
Arm Type
Experimental
Arm Description
Once daily oral dose of 4 mg fedovapagon for 12 weeks
Arm Title
sugar pill
Arm Type
Placebo Comparator
Arm Description
Once daily oral dose of placebo for 12 weeks
Intervention Type
Drug
Intervention Name(s)
fedovapagon 1 mg
Intervention Type
Drug
Intervention Name(s)
fedovapagon 2 mg
Intervention Type
Drug
Intervention Name(s)
fedovapagon 4 mg
Intervention Type
Drug
Intervention Name(s)
Placebo ( sugar pill)
Primary Outcome Measure Information:
Title
Change in the mean nocturnal urine voids
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in the mean nocturnal urine voids
Time Frame
4 weeks
Title
Change in the mean time to first nocturnal void
Time Frame
4 weeks
Title
Change in the mean time to first nocturnal void
Time Frame
12 weeks
Title
Change in Nocturia-related quality of life (N-QOL)
Time Frame
4 weeks
Title
Change in Nocturia-related quality of life (N-QOL)
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilary McElwaine-Johnn, BSc, ASM, MBBS, MRCP, MFPM
Organizational Affiliation
Vantia Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Vantia Investigative Center
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Vantia Investigative Center
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
Vantia Investigative Center
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
Vantia Investigative Center
City
Glendale
State/Province
Arizona
Country
United States
Facility Name
Vantia Investigative Center
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Vantia Investigative Center
City
Anaheim
State/Province
California
Country
United States
Facility Name
Vantia Investigative Center
City
Long Beach
State/Province
California
Country
United States
Facility Name
Vantia Investigative Center
City
San Diego
State/Province
California
Country
United States
Facility Name
Vantia Investigative Center
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Vantia Investigative Center
City
Englewood
State/Province
Colorado
Country
United States
Facility Name
Vantia Investigative Center
City
Milford
State/Province
Connecticut
Country
United States
Facility Name
Vantia Investigative Center
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Vantia Investigative Center
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Vantia Investigative Center
City
Daytona Beach
State/Province
Florida
Country
United States
Facility Name
Vantia Investigative Center
City
DeLand
State/Province
Florida
Country
United States
Facility Name
Vantia Investigative Center
City
Naples
State/Province
Florida
Country
United States
Facility Name
Vantia Investigative Center
City
Ocala
State/Province
Florida
Country
United States
Facility Name
Vantia Investigative Center
City
St. Petersburg
State/Province
Florida
Country
United States
Facility Name
Vantia Investigative Center
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Vantia Investigative Center
City
Coeur d'Alene
State/Province
Idaho
Country
United States
Facility Name
Vantia Investigative Center
City
Meridian
State/Province
Idaho
Country
United States
Facility Name
Vantia Investigative Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Vantia Investigative Center
City
Evansville
State/Province
Indiana
Country
United States
Facility Name
Vantia Investigative Center
City
Jeffersonville
State/Province
Indiana
Country
United States
Facility Name
Vantia Investigative Center
City
Paducah
State/Province
Kentucky
Country
United States
Facility Name
Vantia Investigative Center
City
Metairie
State/Province
Louisiana
Country
United States
Facility Name
Vantia Investigative Center
City
Greenbelt
State/Province
Maryland
Country
United States
Facility Name
Vantia Investigative Center
City
Rochester
State/Province
Michigan
Country
United States
Facility Name
Vantia Investigative Center
City
Edina
State/Province
Minnesota
Country
United States
Facility Name
Vantia Investigative Center
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Vantia Investigative Center
City
Brick
State/Province
New Jersey
Country
United States
Facility Name
Vantia Investigative Center
City
Englewood
State/Province
New Jersey
Country
United States
Facility Name
Vantia Investigative Center
City
Lawrenceville
State/Province
New Jersey
Country
United States
Facility Name
Vantia Investigative Center
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Vantia Investigative Center
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Vantia Investigative Center
City
Endwell
State/Province
New York
Country
United States
Facility Name
Vantia Investigative Center
City
Garden City
State/Province
New York
Country
United States
Facility Name
Vantia Investigative Center
City
New York
State/Province
New York
Country
United States
Facility Name
Vantia Investigative Center
City
Poughkeepsie
State/Province
New York
Country
United States
Facility Name
Vantia Investigative Center
City
Concord
State/Province
North Carolina
Country
United States
Facility Name
Vantia Investigative Center
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Vantia Investigative Center
City
Winston Salem
State/Province
North Carolina
Country
United States
Facility Name
Vantia Investigative Center
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Vantia Investigative Center
City
Bethany
State/Province
Oklahoma
Country
United States
Facility Name
Vantia Investigative Center
City
Bala Cynwyd
State/Province
Pennsylvania
Country
United States
Facility Name
Vantia Investigative Center
City
Warwick
State/Province
Rhode Island
Country
United States
Facility Name
Vantia Investigative Center
City
Mytrle Beach
State/Province
South Carolina
Country
United States
Facility Name
Vantia Investigative Center
City
Dakota Dunes
State/Province
South Dakota
Country
United States
Facility Name
Vantia Investigative Center
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Vantia Investigative Center
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Vantia Investigative Center
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
Vantia Investigative Center
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Vantia Investigative Center
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Vantia Investigative Center
City
Virginia Beach
State/Province
Virginia
Country
United States
Facility Name
Vantia Investigative Center
City
Burien
State/Province
Washington
Country
United States
Facility Name
Vantia Investigative Center
City
Middleton
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Dose Range Finding Study of Fedovapagon in Men With Nocturia

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