Dose Range Finding Study of Fedovapagon in Men With Nocturia
NCT ID: NCT01656239
Last Updated: 2014-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
358 participants
INTERVENTIONAL
2012-08-31
2013-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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fedovapagon 1 mg
Once daily oral dose of 1 mg fedovapagon for 12 weeks
fedovapagon 1 mg
fedovapagon 2 mg
Once daily oral dose of 2 mg fedovapagon for 12 weeks
fedovapagon 2 mg
fedovapagon 4 mg
Once daily oral dose of 4 mg fedovapagon for 12 weeks
fedovapagon 4 mg
sugar pill
Once daily oral dose of placebo for 12 weeks
Placebo ( sugar pill)
Interventions
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fedovapagon 1 mg
fedovapagon 2 mg
fedovapagon 4 mg
Placebo ( sugar pill)
Eligibility Criteria
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Inclusion Criteria
* 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
55 Years
MALE
No
Sponsors
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Vantia Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Hilary McElwaine-Johnn, BSc, ASM, MBBS, MRCP, MFPM
Role: STUDY_DIRECTOR
Vantia Ltd
Locations
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Vantia Investigative Center
Birmingham, Alabama, United States
Vantia Investigative Center
Huntsville, Alabama, United States
Vantia Investigative Center
Mobile, Alabama, United States
Vantia Investigative Center
Glendale, Arizona, United States
Vantia Investigative Center
Tucson, Arizona, United States
Vantia Investigative Center
Anaheim, California, United States
Vantia Investigative Center
Long Beach, California, United States
Vantia Investigative Center
San Diego, California, United States
Vantia Investigative Center
Denver, Colorado, United States
Vantia Investigative Center
Englewood, Colorado, United States
Vantia Investigative Center
Milford, Connecticut, United States
Vantia Investigative Center
Aventura, Florida, United States
Vantia Investigative Center
Clearwater, Florida, United States
Vantia Investigative Center
Daytona Beach, Florida, United States
Vantia Investigative Center
DeLand, Florida, United States
Vantia Investigative Center
Naples, Florida, United States
Vantia Investigative Center
Ocala, Florida, United States
Vantia Investigative Center
St. Petersburg, Florida, United States
Vantia Investigative Center
Tampa, Florida, United States
Vantia Investigative Center
Coeur d'Alene, Idaho, United States
Vantia Investigative Center
Meridian, Idaho, United States
Vantia Investigative Center
Chicago, Illinois, United States
Vantia Investigative Center
Evansville, Indiana, United States
Vantia Investigative Center
Jeffersonville, Indiana, United States
Vantia Investigative Center
Paducah, Kentucky, United States
Vantia Investigative Center
Metairie, Louisiana, United States
Vantia Investigative Center
Greenbelt, Maryland, United States
Vantia Investigative Center
Rochester, Michigan, United States
Vantia Investigative Center
Edina, Minnesota, United States
Vantia Investigative Center
Omaha, Nebraska, United States
Vantia Investigative Center
Brick, New Jersey, United States
Vantia Investigative Center
Englewood, New Jersey, United States
Vantia Investigative Center
Lawrenceville, New Jersey, United States
Vantia Investigative Center
Albuquerque, New Mexico, United States
Vantia Investigative Center
Brooklyn, New York, United States
Vantia Investigative Center
Endwell, New York, United States
Vantia Investigative Center
Garden City, New York, United States
Vantia Investigative Center
New York, New York, United States
Vantia Investigative Center
Poughkeepsie, New York, United States
Vantia Investigative Center
Concord, North Carolina, United States
Vantia Investigative Center
Raleigh, North Carolina, United States
Vantia Investigative Center
Winston-Salem, North Carolina, United States
Vantia Investigative Center
Cincinnati, Ohio, United States
Vantia Investigative Center
Bethany, Oklahoma, United States
Vantia Investigative Center
Bala-Cynwyd, Pennsylvania, United States
Vantia Investigative Center
Warwick, Rhode Island, United States
Vantia Investigative Center
Mytrle Beach, South Carolina, United States
Vantia Investigative Center
Dakota Dunes, South Dakota, United States
Vantia Investigative Center
Nashville, Tennessee, United States
Vantia Investigative Center
Dallas, Texas, United States
Vantia Investigative Center
Fort Worth, Texas, United States
Vantia Investigative Center
San Antonio, Texas, United States
Vantia Investigative Center
Richmond, Virginia, United States
Vantia Investigative Center
Virginia Beach, Virginia, United States
Vantia Investigative Center
Burien, Washington, United States
Vantia Investigative Center
Middleton, Wisconsin, United States
Countries
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Other Identifiers
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483-009
Identifier Type: -
Identifier Source: org_study_id
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