NocturiaPhase 2/3EQUINOCNCT02637960
Efficacy Study of Fedovapagon for Nocturia in Men With Benign Prostatic Hyperplasia (BPH)
A Phase 2/3 study testing Fedovapagon 2 mg in people with Nocturia, run by Vantia Ltd at 48 sites in United States.
Trial summary
This study will investigate the efficacy and safety of fedovapagon in the treatment of nocturia in men with BPH. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Nocturia
- What is being tested?
- Fedovapagon 2 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 432 participants
- Where
- 48 sitesUnited States
- Study dates
- Mar 2016to Aug 2017
- Phase
- Phase 2/3
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
United States48 sites
Vantia Investigative Center
Akron, Ohio
Vantia Investigative Center
Albuquerque, New Mexico
Vantia Investigative Center
Anniston, Alabama
Vantia Investigative Center
Aventura, Florida
Vantia Investigative Center
Avon, Indiana
Vantia Investigative Center
Bradenton, Florida
Vantia Investigative Center
Bristol, Tennessee
Vantia Investigative Center
Cary, North Carolina
Vantia Investigative Center
Charleston, South Carolina
Vantia Investigative Center
Clearwater, Florida
Vantia Investigative Center
Clinton, Utah
Vantia Investigative Center
Concord, North Carolina
Vantia Investigative Center
Coral Gables, Florida
Vantia Investigative Center
Dallas, Texas
Vantia Investigative Center
DeLand, Florida
Vantia Investigative Center
Englewood, New Jersey
Vantia Investigative Center
Garden City, New York
Vantia Investigative Center
Goodyear, Arizona
Vantia Investigative Center
Greenbelt, Maryland
Vantia Investigative Center
Greer, South Carolina
Vantia Investigative Center
Hialeah, Florida
Vantia Investigative Center
High Point, North Carolina
Vantia Investigative Center
Houston, Texas
Vantia Investigative Center
Lawrenceville, New Jersey
Vantia Investigative Center
Lincoln, California
Vantia Investigative Center
Miami, Florida
Vantia Investigative Center
Missoula, Montana
Vantia Investigative Center
Mt. Pleasant, South Carolina
Vantia Investigative Center
Murrieta, California
Vantia Investigative Center
New York, New York
Vantia Investigative Center
Newburgh, New York
Vantia Investigative Center
Ocala, Florida
Vantia Investigative Center
Ogden, Utah
Vantia Investigative Center
Omaha, Nebraska
Vantia Investigative Center
Pembroke Pines, Florida
Vantia Investigative Center
Poughkeepsie, New York
Vantia Investigative Center
Raleigh, North Carolina
Vantia Investigative Center
Richmond, Virginia
Vantia Investigative Center
Salt Lake City, Utah
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
Topeka, Kansas
Vantia Investigative Center
Warwick, Rhode Island
Vantia Investigative Center
Wichita, Kansas
Vantia Investigative Center
Wilmington, North Carolina
Vantia Investigative Center
Winston-Salem, North Carolina
About this study
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)
This study will investigate the efficacy and safety of fedovapagon in the treatment of nocturia in men with BPH.
Read the 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.
- Conditions
- Nocturia
- Being tested
- Fedovapagon 2 mg, Placebo
- Keywords
- VA106483, fedovapagon, BPH, nocturia, EQUINOC
- Medical subject headings
- Nocturia, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fedovapagon 2 mgDrug
One daily dose of 2 mg fedovapagon for 12 weeks
PlaceboDrug
One daily dose of placebo (matched to fedovapagon) for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fedovapagon 2 mg | Experimental | One daily dose of 2 mg fedovapagon for 12 weeks Receives: Drug: Fedovapagon 2 mg |
| Placebo matched to fedovapagon | Experimental | One daily dose of placebo (matched to fedovapagon) for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the mean number of night-time voids
Measured: 12 weeks
Change in mean patient reported nocturia bother score
Measured: 12 weeks
Secondary outcomes (11)
Change in the mean number of night-time voids
Measured: 1 week
Change in the mean number of night-time voids
Measured: 4 weeks
Change in mean patient reported nocturia bother score
Measured: 1 week
Change in mean patient reported nocturia bother score
Measured: 4 weeks
Change in mean night-time urine production, absolute and as a proportion of 24 hour urine production
Measured: 2 months
Change in mean functional bladder capacity
Measured: 2 months
Change in International Prostate Symptom Score (IPSS)
Measured: 4 weeks
Change in International Prostate Symptom Score (IPSS)
Measured: 12 weeks
Change in N-QOL Score
Measured: 4 weeks
Change in N-QOL Score
Measured: 12 weeks
Number and type of Adverse Events
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 posted22 Dec 2015 (estimated)
- Study startMar 2016
- Primary completionJul 2017
- Study completionAug 2017
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantia Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Gittelman, MD, FACS, Principal investigator, South Florida Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637960
- Sponsor's protocol ID
- 483-013
- Acronym
- EQUINOC
- Status last verified
- Oct 2018
- First submitted
- 17 Dec 2015
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02637960
- Acronym / sponsor ID
- EQUINOC / 483-013
- Conditions
- Nocturia
- Keywords
- VA106483, fedovapagon, BPH, nocturia, EQUINOC
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Vantia LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 22 Dec 2015 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fedovapagon 2 mg | Experimental | Drug: Fedovapagon 2 mgOne daily dose of 2 mg fedovapagon for 12 weeks |
| Placebo matched to fedovapagon | Experimental | Drug: PlaceboOne daily dose of placebo (matched to fedovapagon) for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
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 2 mgOne daily dose of 2 mg fedovapagon for 12 weeks | Drug | Fedovapagon 2 mg |
| PlaceboOne daily dose of placebo (matched to fedovapagon) for 12 weeks | Drug | Placebo matched to fedovapagon |
Primary outcome
Change in the mean number of night-time voids
Time frame: 12 weeks
Change in mean patient reported nocturia bother score
Time frame: 12 weeks
11 secondary outcomes
Change in the mean number of night-time voids
Time frame: 1 week
Change in the mean number of night-time voids
Time frame: 4 weeks
Change in mean patient reported nocturia bother score
Time frame: 1 week
Change in mean patient reported nocturia bother score
Time frame: 4 weeks
Change in mean night-time urine production, absolute and as a proportion of 24 hour urine production
Time frame: 2 months
Change in mean functional bladder capacity
Time frame: 2 months
Change in International Prostate Symptom Score (IPSS)
Time frame: 4 weeks
Change in International Prostate Symptom Score (IPSS)
Time frame: 12 weeks
Change in N-QOL Score
Time frame: 4 weeks
Change in N-QOL Score
Time frame: 12 weeks
Number and type of Adverse Events
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 31 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Marc Gittelman, MD, FACS principal investigator
South Florida Medical Research
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fedovapagon 2 mg in people with Nocturia, run by Vantia Ltd at 48 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 6 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 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 number of night-time voids (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 31 Oct 2018.