Dose Range Finding Study of Fedovapagon in Men With Nocturia
This study is currently recruiting participants.
Verified February 2013 by Vantia Ltd
Sponsor:
Vantia Ltd
Information provided by (Responsible Party):
Vantia Ltd
ClinicalTrials.gov Identifier:
NCT01656239
First received: July 31, 2012
Last updated: February 19, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Nocturia |
Drug: fedovapagon 1 mg Drug: fedovapagon 2 mg Drug: fedovapagon 4 mg Drug: Placebo ( sugar pill) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Vantia Ltd:
Primary Outcome Measures:
- Change in the mean nocturnal urine voids [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in the mean nocturnal urine voids [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Change in the mean time to first nocturnal void [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Change in the mean time to first nocturnal void [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in Nocturia-related quality of life (N-QOL) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Change in Nocturia-related quality of life (N-QOL) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 358 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: fedovapagon 1 mg
Once daily oral dose of 1 mg fedovapagon for 12 weeks
|
Drug: fedovapagon 1 mg |
|
Experimental: fedovapagon 2 mg
Once daily oral dose of 2 mg fedovapagon for 12 weeks
|
Drug: fedovapagon 2 mg |
|
Experimental: fedovapagon 4 mg
Once daily oral dose of 4 mg fedovapagon for 12 weeks
|
Drug: fedovapagon 4 mg |
|
Placebo Comparator: sugar pill
Once daily oral dose of placebo for 12 weeks
|
Drug: Placebo ( sugar pill) |
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| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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:
-
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656239
Hide Study Locations
Contacts
| Contact: Clinical Development Support | 483-009@vantia.com |
Hide Study LocationsLocations
| United States, Alabama | |
| Vantia Investigative Center | Recruiting |
| Birmingham, Alabama, United States | |
| Vantia Investigative Center | Recruiting |
| Huntsville, Alabama, United States | |
| Vantia Investigative Center | Recruiting |
| Mobile, Alabama, United States | |
| United States, Arizona | |
| Vantia Investigative Center | Recruiting |
| Glendale, Arizona, United States | |
| Vantia Investigative Center | Recruiting |
| Tucson, Arizona, United States | |
| United States, California | |
| Vantia Investigative Center | Recruiting |
| Anaheim, California, United States | |
| Vantia Investigative Center | Recruiting |
| Long Beach, California, United States | |
| Vantia Investigative Center | Recruiting |
| San Diego, California, United States | |
| United States, Colorado | |
| Vantia Investigative Center | Recruiting |
| Denver, Colorado, United States | |
| Vantia Investigative Center | Recruiting |
| Englewood, Colorado, United States | |
| United States, Connecticut | |
| Vantia Investigative Center | Recruiting |
| Milford, Connecticut, United States | |
| United States, Florida | |
| Vantia Investigative Center | Recruiting |
| Aventura, Florida, United States | |
| Vantia Investigative Center | Recruiting |
| Clearwater, Florida, United States | |
| Vantia Investigative Center | Recruiting |
| Daytona Beach, Florida, United States | |
| Vantia Investigative Center | Recruiting |
| DeLand, Florida, United States | |
| Vantia Investigative Center | Recruiting |
| Naples, Florida, United States | |
| Vantia Investigative Center | Recruiting |
| Ocala, Florida, United States | |
| Vantia Investigative Center | Recruiting |
| St. Petersburg, Florida, United States | |
| Vantia Investigative Center | Recruiting |
| Tampa, Florida, United States | |
| United States, Idaho | |
| Vantia Investigative Center | Recruiting |
| Coeur d'Alene, Idaho, United States | |
| Vantia Investigative Center | Recruiting |
| Meridian, Idaho, United States | |
| United States, Illinois | |
| Vantia Investigative Center | Recruiting |
| Chicago, Illinois, United States | |
| United States, Indiana | |
| Vantia Investigative Center | Recruiting |
| Evansville, Indiana, United States | |
| Vantia Investigative Center | Recruiting |
| Jeffersonville, Indiana, United States | |
| United States, Kentucky | |
| Vantia Investigative Center | Recruiting |
| Paducah, Kentucky, United States | |
| United States, Louisiana | |
| Vantia Investigative Center | Recruiting |
| Metairie, Louisiana, United States | |
| United States, Maryland | |
| Vantia Investigative Center | Recruiting |
| Greenbelt, Maryland, United States | |
| United States, Michigan | |
| Vantia Investigative Center | Recruiting |
| Rochester, Michigan, United States | |
| United States, Minnesota | |
| Vantia Investigative Center | Recruiting |
| Edina, Minnesota, United States | |
| United States, Nebraska | |
| Vantia Investigative Center | Recruiting |
| Omaha, Nebraska, United States | |
| United States, New Jersey | |
| Vantia Investigative Center | Recruiting |
| Brick, New Jersey, United States | |
| Vantia Investigative Center | Recruiting |
| Englewood, New Jersey, United States | |
| Vantia Investigative Center | Recruiting |
| Lawrenceville, New Jersey, United States | |
| United States, New Mexico | |
| Vantia Investigative Center | Recruiting |
| Albuquerque, New Mexico, United States | |
| United States, New York | |
| Vantia Investigative Center | Recruiting |
| Brooklyn, New York, United States | |
| Vantia Investigative Center | Recruiting |
| Endwell, New York, United States | |
| Vantia Investigative Center | Recruiting |
| Garden City, New York, United States | |
| Vantia Investigative Center | Recruiting |
| New York, New York, United States | |
| Vantia Investigative Center | Recruiting |
| Poughkeepsie, New York, United States | |
| United States, North Carolina | |
| Vantia Investigative Center | Recruiting |
| Concord, North Carolina, United States | |
| Vantia Investigative Center | Recruiting |
| Raleigh, North Carolina, United States | |
| Vantia Investigative Center | Recruiting |
| Winston Salem, North Carolina, United States | |
| United States, Ohio | |
| Vantia Investigative Center | Recruiting |
| Cincinnati, Ohio, United States | |
| United States, Oklahoma | |
| Vantia Investigative Center | Recruiting |
| Bethany, Oklahoma, United States | |
| United States, Pennsylvania | |
| Vantia Investigative Center | Recruiting |
| Bala Cynwyd, Pennsylvania, United States | |
| United States, Rhode Island | |
| Vantia Investigative Center | Recruiting |
| Warwick, Rhode Island, United States | |
| United States, South Carolina | |
| Vantia Investigative Center | Recruiting |
| Mytrle Beach, South Carolina, United States | |
| United States, South Dakota | |
| Vantia Investigative Center | Recruiting |
| Dakota Dunes, South Dakota, United States | |
| United States, Tennessee | |
| Vantia Investigative Center | Recruiting |
| Nashville, Tennessee, United States | |
| United States, Texas | |
| Vantia Investigative Center | Recruiting |
| Dallas, Texas, United States | |
| Vantia Investigative Center | Recruiting |
| Fort Worth, Texas, United States | |
| Vantia Investigative Center | Recruiting |
| San Antonio, Texas, United States | |
| United States, Virginia | |
| Vantia Investigative Center | Recruiting |
| Richmond, Virginia, United States | |
| Vantia Investigative Center | Recruiting |
| Virginia Beach, Virginia, United States | |
| United States, Washington | |
| Vantia Investigative Center | Recruiting |
| Burien, Washington, United States | |
| United States, Wisconsin | |
| Vantia Investigative Center | Recruiting |
| Middleton, Wisconsin, United States | |
Sponsors and Collaborators
Vantia Ltd
Investigators
| Study Director: | Hilary McElwaine-Johnn, BSc, ASM, MBBS, MRCP, MFPM | Vantia Ltd |
More Information
No publications provided
| Responsible Party: | Vantia Ltd |
| ClinicalTrials.gov Identifier: | NCT01656239 History of Changes |
| Other Study ID Numbers: | 483-009 |
| Study First Received: | July 31, 2012 |
| Last Updated: | February 19, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Vantia Ltd:
|
VA106483, fedovapagon, Nocturia, males, nocturnal voids, anti-diuretic |
Additional relevant MeSH terms:
|
Nocturia Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013