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Efficacy Study of Fedovapagon for Nocturia in Men With Benign Prostatic Hyperplasia (BPH) (EQUINOC)

Primary Purpose

Nocturia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fedovapagon 2 mg
Placebo
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, BPH, nocturia, EQUINOC

Eligibility Criteria

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

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:

-

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Fedovapagon 2 mg

Placebo matched to fedovapagon

Arm Description

One daily dose of 2 mg fedovapagon for 12 weeks

One daily dose of placebo (matched to fedovapagon) for 12 weeks

Outcomes

Primary Outcome Measures

Change in the mean number of night-time voids
Change in mean patient reported nocturia bother score

Secondary Outcome Measures

Change in the mean number of night-time voids
Change in the mean number of night-time voids
Change in mean patient reported nocturia bother score
Change in mean patient reported nocturia bother score
Change in mean night-time urine production, absolute and as a proportion of 24 hour urine production
Change in mean functional bladder capacity
Change in International Prostate Symptom Score (IPSS)
Change in International Prostate Symptom Score (IPSS)
Change in N-QOL Score
Change in N-QOL Score
Number and type of Adverse Events

Full Information

First Posted
December 17, 2015
Last Updated
October 29, 2018
Sponsor
Vantia Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02637960
Brief Title
Efficacy Study of Fedovapagon for Nocturia in Men With Benign Prostatic Hyperplasia (BPH)
Acronym
EQUINOC
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
August 2017 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia
Keywords
VA106483, fedovapagon, BPH, nocturia, EQUINOC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
432 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fedovapagon 2 mg
Arm Type
Experimental
Arm Description
One daily dose of 2 mg fedovapagon for 12 weeks
Arm Title
Placebo matched to fedovapagon
Arm Type
Experimental
Arm Description
One daily dose of placebo (matched to fedovapagon) for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Fedovapagon 2 mg
Intervention Description
One daily dose of 2 mg fedovapagon for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One daily dose of placebo (matched to fedovapagon) for 12 weeks
Primary Outcome Measure Information:
Title
Change in the mean number of night-time voids
Time Frame
12 weeks
Title
Change in mean patient reported nocturia bother score
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in the mean number of night-time voids
Time Frame
1 week
Title
Change in the mean number of night-time voids
Time Frame
4 weeks
Title
Change in mean patient reported nocturia bother score
Time Frame
1 week
Title
Change in mean patient reported nocturia bother score
Time Frame
4 weeks
Title
Change in mean night-time urine production, absolute and as a proportion of 24 hour urine production
Time Frame
2 months
Title
Change in mean functional bladder capacity
Time Frame
2 months
Title
Change in International Prostate Symptom Score (IPSS)
Time Frame
4 weeks
Title
Change in International Prostate Symptom Score (IPSS)
Time Frame
12 weeks
Title
Change in N-QOL Score
Time Frame
4 weeks
Title
Change in N-QOL Score
Time Frame
12 weeks
Title
Number and type of Adverse Events
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Gittelman, MD, FACS
Organizational Affiliation
South Florida Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vantia Investigative Center
City
Anniston
State/Province
Alabama
Country
United States
Facility Name
Vantia Investigative Center
City
Goodyear
State/Province
Arizona
Country
United States
Facility Name
Vantia Investigative Center
City
Lincoln
State/Province
California
Country
United States
Facility Name
Vantia Investigative Center
City
Murrieta
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
Aventura
State/Province
Florida
Country
United States
Facility Name
Vantia Investigative Center
City
Bradenton
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
Coral Gables
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
Hialeah
State/Province
Florida
Country
United States
Facility Name
Vantia Investigative Center
City
Miami
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
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
Vantia Investigative Center
City
Saint 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
Avon
State/Province
Indiana
Country
United States
Facility Name
Vantia Investigative Center
City
Topeka
State/Province
Kansas
Country
United States
Facility Name
Vantia Investigative Center
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Vantia Investigative Center
City
Greenbelt
State/Province
Maryland
Country
United States
Facility Name
Vantia Investigative Center
City
Missoula
State/Province
Montana
Country
United States
Facility Name
Vantia Investigative Center
City
Omaha
State/Province
Nebraska
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
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
Newburgh
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
Cary
State/Province
North Carolina
Country
United States
Facility Name
Vantia Investigative Center
City
Concord
State/Province
North Carolina
Country
United States
Facility Name
Vantia Investigative Center
City
High Point
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
Wilmington
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
Akron
State/Province
Ohio
Country
United States
Facility Name
Vantia Investigative Center
City
Warwick
State/Province
Rhode Island
Country
United States
Facility Name
Vantia Investigative Center
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Vantia Investigative Center
City
Greer
State/Province
South Carolina
Country
United States
Facility Name
Vantia Investigative Center
City
Mount Pleasant
State/Province
South Carolina
Country
United States
Facility Name
Vantia Investigative Center
City
Bristol
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
Houston
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
Clinton
State/Province
Utah
Country
United States
Facility Name
Vantia Investigative Center
City
Ogden
State/Province
Utah
Country
United States
Facility Name
Vantia Investigative Center
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Vantia Investigative Center
City
Richmond
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy Study of Fedovapagon for Nocturia in Men With Benign Prostatic Hyperplasia (BPH)

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