Dose Range Finding Study of Fedovapagon in Men With Nocturia

Nocturia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656239
• Other study ID #: 483-009
• Status: Completed
• Phase: Phase 2
• First received: July 31, 2012
• Last updated: June 18, 2014
• Start date: August 2012
• Est. completion date: September 2013

Study information

• Verified date: June 2014
• Source: Vantia Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nocturia

Intervention

Drug:
• fedovapagon 1 mg

• fedovapagon 2 mg

• fedovapagon 4 mg

• Placebo ( sugar pill)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Vantia Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the mean nocturnal urine voids		12 weeks	No
Secondary	Change in the mean nocturnal urine voids		4 weeks	No
Secondary	Change in the mean time to first nocturnal void		4 weeks	No
Secondary	Change in the mean time to first nocturnal void		12 weeks	No
Secondary	Change in Nocturia-related quality of life (N-QOL)		4 weeks	No
Secondary	Change in Nocturia-related quality of life (N-QOL)		12 weeks	No