Clinical trial NCT02637960: Efficacy Study of Fedovapagon for Nocturia in Men With Benign Prostatic Hyperplasia (BPH)
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Nocturia
Keywords: VA106483, fedovapagon, BPH, nocturia, EQUINOC
Lead sponsor: Vantia Ltd
Sponsor class: INDUSTRY
First posted: 2015-12-22
Enrollment: 432
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Change in the mean number of night-time voids
timeFrame: 12 weeks
measure: Change in mean patient reported nocturia bother score
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in the mean number of night-time voids
timeFrame: 1 week
measure: Change in the mean number of night-time voids
timeFrame: 4 weeks
measure: Change in mean patient reported nocturia bother score
timeFrame: 1 week
measure: Change in mean patient reported nocturia bother score
timeFrame: 4 weeks
measure: Change in mean night-time urine production, absolute and as a proportion of 24 hour urine production
timeFrame: 2 months
measure: Change in mean functional bladder capacity
timeFrame: 2 months
measure: Change in International Prostate Symptom Score (IPSS)
timeFrame: 4 weeks
measure: Change in International Prostate Symptom Score (IPSS)
timeFrame: 12 weeks
measure: Change in N-QOL Score
timeFrame: 4 weeks
measure: Change in N-QOL Score
timeFrame: 12 weeks
measure: Number and type of Adverse Events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Vantia Investigative Center
state: Alabama
city: Goodyear
country: United States
facility: Vantia Investigative Center
state: Arizona
city: Lincoln
country: United States
facility: Vantia Investigative Center
state: California
city: Murrieta
country: United States
facility: Vantia Investigative Center
state: California
city: San Diego
country: United States
facility: Vantia Investigative Center
state: California
city: Aventura
country: United States
facility: Vantia Investigative Center
state: Florida
city: Bradenton
country: United States
facility: Vantia Investigative Center
state: Florida
city: Clearwater
country: United States
facility: Vantia Investigative Center
state: Florida
city: Coral Gables
country: United States
facility: Vantia Investigative Center
state: Florida
city: DeLand
country: United States
facility: Vantia Investigative Center
state: Florida
city: Hialeah
country: United States
facility: Vantia Investigative Center
state: Florida
city: Miami
country: United States
facility: Vantia Investigative Center
state: Florida
city: Ocala
country: United States
facility: Vantia Investigative Center
state: Florida
city: Pembroke Pines
country: United States
facility: Vantia Investigative Center
state: Florida
city: Saint Petersburg
country: United States
facility: Vantia Investigative Center
state: Florida
city: Tampa
country: United States
facility: Vantia Investigative Center
state: Florida
city: Avon
country: United States
facility: Vantia Investigative Center
state: Indiana
city: Topeka
country: United States
facility: Vantia Investigative Center
state: Kansas
city: Wichita
country: United States
facility: Vantia Investigative Center
state: Kansas
city: Greenbelt
country: United States
facility: Vantia Investigative Center
state: Maryland
city: Missoula
country: United States
facility: Vantia Investigative Center
state: Montana
city: Omaha
country: United States
facility: Vantia Investigative Center
state: Nebraska
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: 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: Newburgh
country: United States
facility: Vantia Investigative Center
state: New York
city: Poughkeepsie
country: United States
facility: Vantia Investigative Center
state: New York
city: Cary
country: United States
facility: Vantia Investigative Center
state: North Carolina
city: Concord
country: United States
facility: Vantia Investigative Center
state: North Carolina
city: High Point
country: United States
facility: Vantia Investigative Center
state: North Carolina
city: Raleigh
country: United States
facility: Vantia Investigative Center
state: North Carolina
city: Wilmington
country: United States
facility: Vantia Investigative Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Vantia Investigative Center
state: North Carolina
city: Akron
country: United States
facility: Vantia Investigative Center
state: Ohio
city: Warwick
country: United States
facility: Vantia Investigative Center
state: Rhode Island
city: Charleston
country: United States
facility: Vantia Investigative Center
state: South Carolina
city: Greer
country: United States
facility: Vantia Investigative Center
state: South Carolina
city: Mount Pleasant
country: United States
facility: Vantia Investigative Center
state: South Carolina
city: Bristol
country: United States
facility: Vantia Investigative Center
state: Tennessee
city: Dallas
country: United States
facility: Vantia Investigative Center
state: Texas
city: Houston
country: United States
facility: Vantia Investigative Center
state: Texas
city: San Antonio
country: United States
facility: Vantia Investigative Center
state: Texas
city: Clinton
country: United States
facility: Vantia Investigative Center
state: Utah
city: Ogden
country: United States
facility: Vantia Investigative Center
state: Utah
city: Salt Lake City
country: United States
facility: Vantia Investigative Center
state: Utah
city: Richmond
country: United States
facility: Vantia Investigative Center
state: Virginia
Study officials:
affiliation: South Florida Medical Research
name: Marc Gittelman, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: