NocturiaPhase 2NCT01656239
Dose Range Finding Study of Fedovapagon in Men With Nocturia
A Phase 2 study testing fedovapagon 1 mg, fedovapagon 2 mg and fedovapagon 4 mg in people with Nocturia, run by Vantia Ltd at 56 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 55 years and older, men only
- Conditions the study is for
- Nocturia
- What is being tested?
- fedovapagon 1 mg, fedovapagon 2 mg and fedovapagon 4 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 358 participants
- Where
- 56 sitesUnited States
- Study dates
- Aug 2012to Sep 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
56 sites in 1 country.
56 sites in 1 country
United States56 sites
Vantia Investigative Center
Albuquerque, New Mexico
Vantia Investigative Center
Anaheim, California
Vantia Investigative Center
Aventura, Florida
Vantia Investigative Center
Bala-Cynwyd, Pennsylvania
Vantia Investigative Center
Bethany, Oklahoma
Vantia Investigative Center
Birmingham, Alabama
Vantia Investigative Center
Brick, New Jersey
Vantia Investigative Center
Brooklyn, New York
Vantia Investigative Center
Burien, Washington
Vantia Investigative Center
Chicago, Illinois
Vantia Investigative Center
Cincinnati, Ohio
Vantia Investigative Center
Clearwater, Florida
Vantia Investigative Center
Coeur d'Alene, Idaho
Vantia Investigative Center
Concord, North Carolina
Vantia Investigative Center
Dakota Dunes, South Dakota
Vantia Investigative Center
Dallas, Texas
Vantia Investigative Center
Daytona Beach, Florida
Vantia Investigative Center
DeLand, Florida
Vantia Investigative Center
Denver, Colorado
Vantia Investigative Center
Edina, Minnesota
Vantia Investigative Center
Endwell, New York
Vantia Investigative Center
Englewood, Colorado
Vantia Investigative Center
Englewood, New Jersey
Vantia Investigative Center
Evansville, Indiana
Vantia Investigative Center
Fort Worth, Texas
Vantia Investigative Center
Garden City, New York
Vantia Investigative Center
Glendale, Arizona
Vantia Investigative Center
Greenbelt, Maryland
Vantia Investigative Center
Huntsville, Alabama
Vantia Investigative Center
Jeffersonville, Indiana
Vantia Investigative Center
Lawrenceville, New Jersey
Vantia Investigative Center
Long Beach, California
Vantia Investigative Center
Meridian, Idaho
Vantia Investigative Center
Metairie, Louisiana
Vantia Investigative Center
Middleton, Wisconsin
Vantia Investigative Center
Milford, Connecticut
Vantia Investigative Center
Mobile, Alabama
Vantia Investigative Center
Mytrle Beach, South Carolina
Vantia Investigative Center
Naples, Florida
Vantia Investigative Center
Nashville, Tennessee
Vantia Investigative Center
New York, New York
Vantia Investigative Center
Ocala, Florida
Vantia Investigative Center
Omaha, Nebraska
Vantia Investigative Center
Paducah, Kentucky
Vantia Investigative Center
Poughkeepsie, New York
Vantia Investigative Center
Raleigh, North Carolina
Vantia Investigative Center
Richmond, Virginia
Vantia Investigative Center
Rochester, Michigan
Vantia Investigative Center
San Antonio, Texas
Vantia Investigative Center
San Diego, California
Vantia Investigative Center
St. Petersburg, Florida
Vantia Investigative Center
Tampa, Florida
Vantia Investigative Center
Tucson, Arizona
Vantia Investigative Center
Virginia Beach, Virginia
Vantia Investigative Center
Warwick, Rhode Island
Vantia Investigative Center
Winston-Salem, North Carolina
About this study
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
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.
Read the 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.
- Conditions
- Nocturia
- Being tested
- fedovapagon 1 mg, fedovapagon 2 mg, fedovapagon 4 mg, Placebo ( sugar pill)
- Keywords
- VA106483, fedovapagon, Nocturia, males, nocturnal voids, anti-diuretic
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fedovapagon 1 mgDrug
fedovapagon 2 mgDrug
fedovapagon 4 mgDrug
Placebo ( sugar pill)Drug
| Study group | Role | What they receive |
|---|---|---|
| fedovapagon 1 mg | Experimental | Once daily oral dose of 1 mg fedovapagon for 12 weeks Receives: Drug: fedovapagon 1 mg |
| fedovapagon 2 mg | Experimental | Once daily oral dose of 2 mg fedovapagon for 12 weeks Receives: Drug: fedovapagon 2 mg |
| fedovapagon 4 mg | Experimental | Once daily oral dose of 4 mg fedovapagon for 12 weeks Receives: Drug: fedovapagon 4 mg |
| sugar pill | Placebo comparator | Once daily oral dose of placebo for 12 weeks Receives: Drug: Placebo ( sugar pill) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the mean nocturnal urine voids
Measured: 12 weeks
Secondary outcomes (5)
Change in the mean nocturnal urine voids
Measured: 4 weeks
Change in the mean time to first nocturnal void
Measured: 4 weeks
Change in the mean time to first nocturnal void
Measured: 12 weeks
Change in Nocturia-related quality of life (N-QOL)
Measured: 4 weeks
Change in Nocturia-related quality of life (N-QOL)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NocturiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantia Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hilary McElwaine-Johnn, BSc, ASM, MBBS, MRCP, MFPM, Study director, Vantia Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656239
- Sponsor's protocol ID
- 483-009
- Status last verified
- Jun 2014
- First submitted
- 31 Jul 2012
- Last updated
- 20 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01656239
- Acronym / sponsor ID
- 483-009
- Conditions
- Nocturia
- Keywords
- VA106483, fedovapagon, Nocturia, males, nocturnal voids, anti-diuretic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Vantia LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 2 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| fedovapagon 1 mg | Experimental | Drug: fedovapagon 1 mgOnce daily oral dose of 1 mg fedovapagon for 12 weeks |
| fedovapagon 2 mg | Experimental | Drug: fedovapagon 2 mgOnce daily oral dose of 2 mg fedovapagon for 12 weeks |
| fedovapagon 4 mg | Experimental | Drug: fedovapagon 4 mgOnce daily oral dose of 4 mg fedovapagon for 12 weeks |
| sugar pill | Placebo comparator | Drug: Placebo ( sugar pill)Once daily oral dose of placebo for 12 weeks |
Who may qualify
- Ages
- 55 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fedovapagon 1 mg | Drug | fedovapagon 1 mg |
| fedovapagon 2 mg | Drug | fedovapagon 2 mg |
| fedovapagon 4 mg | Drug | fedovapagon 4 mg |
| Placebo ( sugar pill) | Drug | sugar pill |
Primary outcome
Change in the mean nocturnal urine voids
Time frame: 12 weeks
5 secondary outcomes
Change in the mean nocturnal urine voids
Time frame: 4 weeks
Change in the mean time to first nocturnal void
Time frame: 4 weeks
Change in the mean time to first nocturnal void
Time frame: 12 weeks
Change in Nocturia-related quality of life (N-QOL)
Time frame: 4 weeks
Change in Nocturia-related quality of life (N-QOL)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2014.
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Not yet recruitingPhase 4
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilary McElwaine-Johnn, BSc, ASM, MBBS, MRCP, MFPM study director
Vantia Ltd
56 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fedovapagon 1 mg, fedovapagon 2 mg and fedovapagon 4 mg in people with Nocturia, run by Vantia Ltd at 56 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the mean nocturnal urine voids (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2014.