Clinical trial NCT01656239: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nocturia
Keywords: VA106483, fedovapagon, Nocturia, males, nocturnal voids, anti-diuretic
Lead sponsor: Vantia Ltd
Sponsor class: INDUSTRY
First posted: 2012-08-02
Enrollment: 358
Sex: MALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

-

Primary outcomes:
measure: Change in the mean nocturnal urine voids
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in the mean nocturnal urine voids
timeFrame: 4 weeks
measure: Change in the mean time to first nocturnal void
timeFrame: 4 weeks
measure: Change in the mean time to first nocturnal void
timeFrame: 12 weeks
measure: Change in Nocturia-related quality of life (N-QOL)
timeFrame: 4 weeks
measure: Change in Nocturia-related quality of life (N-QOL)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Vantia Investigative Center
state: Alabama
city: Huntsville
country: United States
facility: Vantia Investigative Center
state: Alabama
city: Mobile
country: United States
facility: Vantia Investigative Center
state: Alabama
city: Glendale
country: United States
facility: Vantia Investigative Center
state: Arizona
city: Tucson
country: United States
facility: Vantia Investigative Center
state: Arizona
city: Anaheim
country: United States
facility: Vantia Investigative Center
state: California
city: Long Beach
country: United States
facility: Vantia Investigative Center
state: California
city: San Diego
country: United States
facility: Vantia Investigative Center
state: California
city: Denver
country: United States
facility: Vantia Investigative Center
state: Colorado
city: Englewood
country: United States
facility: Vantia Investigative Center
state: Colorado
city: Milford
country: United States
facility: Vantia Investigative Center
state: Connecticut
city: Aventura
country: United States
facility: Vantia Investigative Center
state: Florida
city: Clearwater
country: United States
facility: Vantia Investigative Center
state: Florida
city: Daytona Beach
country: United States
facility: Vantia Investigative Center
state: Florida
city: DeLand
country: United States
facility: Vantia Investigative Center
state: Florida
city: Naples
country: United States
facility: Vantia Investigative Center
state: Florida
city: Ocala
country: United States
facility: Vantia Investigative Center
state: Florida
city: St. Petersburg
country: United States
facility: Vantia Investigative Center
state: Florida
city: Tampa
country: United States
facility: Vantia Investigative Center
state: Florida
city: Coeur d'Alene
country: United States
facility: Vantia Investigative Center
state: Idaho
city: Meridian
country: United States
facility: Vantia Investigative Center
state: Idaho
city: Chicago
country: United States
facility: Vantia Investigative Center
state: Illinois
city: Evansville
country: United States
facility: Vantia Investigative Center
state: Indiana
city: Jeffersonville
country: United States
facility: Vantia Investigative Center
state: Indiana
city: Paducah
country: United States
facility: Vantia Investigative Center
state: Kentucky
city: Metairie
country: United States
facility: Vantia Investigative Center
state: Louisiana
city: Greenbelt
country: United States
facility: Vantia Investigative Center
state: Maryland
city: Rochester
country: United States
facility: Vantia Investigative Center
state: Michigan
city: Edina
country: United States
facility: Vantia Investigative Center
state: Minnesota
city: Omaha
country: United States
facility: Vantia Investigative Center
state: Nebraska
city: Brick
country: United States
facility: Vantia Investigative Center
state: New Jersey
city: Englewood
country: United States
facility: Vantia Investigative Center
state: New Jersey
city: Lawrenceville
country: United States
facility: Vantia Investigative Center
state: New Jersey
city: Albuquerque
country: United States
facility: Vantia Investigative Center
state: New Mexico
city: Brooklyn
country: United States
facility: Vantia Investigative Center
state: New York
city: Endwell
country: United States
facility: Vantia Investigative Center
state: New York
city: Garden City
country: United States
facility: Vantia Investigative Center
state: New York
city: New York
country: United States
facility: Vantia Investigative Center
state: New York
city: Poughkeepsie
country: United States
facility: Vantia Investigative Center
state: New York
city: Concord
country: United States
facility: Vantia Investigative Center
state: North Carolina
city: Raleigh
country: United States
facility: Vantia Investigative Center
state: North Carolina
city: Winston Salem
country: United States
facility: Vantia Investigative Center
state: North Carolina
city: Cincinnati
country: United States
facility: Vantia Investigative Center
state: Ohio
city: Bethany
country: United States
facility: Vantia Investigative Center
state: Oklahoma
city: Bala Cynwyd
country: United States
facility: Vantia Investigative Center
state: Pennsylvania
city: Warwick
country: United States
facility: Vantia Investigative Center
state: Rhode Island
city: Mytrle Beach
country: United States
facility: Vantia Investigative Center
state: South Carolina
city: Dakota Dunes
country: United States
facility: Vantia Investigative Center
state: South Dakota
city: Nashville
country: United States
facility: Vantia Investigative Center
state: Tennessee
city: Dallas
country: United States
facility: Vantia Investigative Center
state: Texas
city: Fort Worth
country: United States
facility: Vantia Investigative Center
state: Texas
city: San Antonio
country: United States
facility: Vantia Investigative Center
state: Texas
city: Richmond
country: United States
facility: Vantia Investigative Center
state: Virginia
city: Virginia Beach
country: United States
facility: Vantia Investigative Center
state: Virginia
city: Burien
country: United States
facility: Vantia Investigative Center
state: Washington
city: Middleton
country: United States
facility: Vantia Investigative Center
state: Wisconsin
Study officials:
affiliation: Vantia Ltd
name: Hilary McElwaine-Johnn, BSc, ASM, MBBS, MRCP, MFPM
role: STUDY_DIRECTOR
References: