NocturiaPhase 2NCT01038843
Efficacy Study of VA106483 in Males With Nocturia.
A Phase 2 study testing VA106483 in people with Nocturia, run by Vantia Ltd at 19 sites in United States.
Trial summary
To investigate the effect of VA106483 on nocturia related clinical outcomes compared to placebo. 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?
- VA106483
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 19 sitesUnited States
- Study dates
- Dec 2009to Aug 2010
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subjects aged ≥18 years (no upper limit) with nocturia
- Generally well (concomitant illness/conditions well controlled)
- Serum sodium within the normal limits
- Normal or not clinically significant prostate specific antigen levels
- Able to comply with the requirements of the study
- Provide written informed consent
Who cannot join
- Prostatic cancer
- Signs or symptoms of heart failure
- Peripheral pitting oedema extending ≥10 cm above the ankle
- Palpable bladder or pelvic mass on abdominal examination
- Enuresis or night-time incontinence
- Excessive nocturnal void frequency
Show all 15Show fewer
- Sleep disorders
- Diabetes insipidus or uncontrolled diabetes mellitus
- Presence of blood or glucose in the urine on urinalysis that is clinically significant
- Urinary tract infection
- Polydipsia
- Syndrome of inappropriate antidiuretic hormone secretion
- Body mass index ≥35
- High calcium levels or low potassium levels
- Other protocol defined eligibility criteria may apply
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Urology Associates of North Texas
Arlington, Texas, 76017
The Urology Team P.A.
Austin, Texas, 78759
South Florida Medical Research
Aventura, Florida, 33180
Medical & Clinical Research Associates
Bay Shore, New York, 11706
Parkhurst Research Organization
Bethany, Oklahoma, 73008
Alabama Research Center, LLC
Birmingham, Alabama, 35209
Discovery Clinical Trials
Celebration, Florida, 34747
Rapid Medical Research, Inc.
Clevland, Ohio, 44122
Avail Clinical Research LLC
DeLand, Florida, 32720
Accumed Research Associates
Garden City, New York, 11530
Urology Center of Florida
Hialeah, Florida, 33012
Tower Urology Medical Group
Los Angeles, California, 90048
Grove Hill Clinical Research
New Britian, Connecticut, 06052
South Broward Research, LLC
Pembroke Pines, Florida, 33027
Hudson Valley Urology, PC
Poughkeepsie, New York, 12601
Health Texas Research Institute
San Antonio, Texas, 78212
Martin Diagnostic Clinic
Tomball, Texas, 77375
Genova Clinical Research
Tucson, Arizona, 85741
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, 02472
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-titration Study to Determine the Efficacy and Safety of VA106483 in Male Subjects With Nocturia
To investigate the effect of VA106483 on nocturia related clinical outcomes compared to placebo.
Read the detailed description
Nocturia, defined as waking to urinate at least once per night between periods of sleep, is a common complaint which increases with age. VA106483 is a non-peptide drug VA106483 that is being developed for the treatment of nocturia in males.
The purpose of this study is to investigate the effect of VA106483 on the number of times the subject needs to get up to urinate (nocturnal void) per night and to determine the effect on the time between the subject's bedtime and the time they first wake up to urinate.
- Conditions
- Nocturia
- Being tested
- VA106483
- Keywords
- VA106483, Nocturia, males, nocturnal voids, anti-diuretic, hyponatraemia
- Medical subject headings
- Nocturia, Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VA106483Drug
Drug: VA106483 Once daily oral dose of 1 mg VA106483 or matching placebo for 14 (+3) days. Once daily oral dose of 2 mg VA106483 or matching placebo for 14 (+3) days. Once daily oral dose of 4 mg VA106483 or matching placebo for 28 days.
Placebo: as above
| Study group | Role | What they receive |
|---|---|---|
| VA106483 1mg | Experimental | Not described Receives: Drug: VA106483 |
| VA106483 2mg | Experimental | Not described Receives: Drug: VA106483 |
| VA106483 4mg | Experimental | Not described Receives: Drug: VA106483 |
| Sugar pill | Placebo comparator | Not described Receives: Drug: VA106483 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the mean number of nocturnal voids per night
Measured: 70 days
Secondary outcomes (5)
Mean duration of first sleep period
Measured: 70 days
Change in nocturia-related quality of life
Measured: 70 days
Incidence and frequency of adverse events
Measured: 70 days
Frequency of hyponatraemia
Measured: 70 days
Change from baseline in safety laboratory parameters
Measured: 70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJul 2010
- Study completionAug 2010
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
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantia Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mira Baron, Principal investigator, Rapid Medical Research, Inc.David Beccia, Principal investigator, Medical & Clinical Research AssociatesKenneth Blaze, Principal investigator, South Broward Research, LLCMitchell Efros, Principal investigator, Accumed Research AssociatesMarc Gittelman, Principal investigator, South Florida Medical ResearchEvan Goldfischer, Principal investigator, Hudson Valley Urology, PCElizabeth Houser, Principal investigator, The Urology Team P.A.Theodore Johnson II, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038843
- Sponsor's protocol ID
- 483-005
- Status last verified
- Jun 2014
- First submitted
- 22 Dec 2009
- 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-titration Study to Determine the Efficacy and Safety of VA106483 in Male Subjects With Nocturia
- ClinicalTrials.gov ID
- NCT01038843
- Acronym / sponsor ID
- 483-005
- Conditions
- Nocturia
- Keywords
- VA106483, Nocturia, males, nocturnal voids, anti-diuretic, hyponatraemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Vantia LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 24 Dec 2009 (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.
To investigate the effect of VA106483 on nocturia related clinical outcomes compared to placebo.
Detailed description
Nocturia, defined as waking to urinate at least once per night between periods of sleep, is a common complaint which increases with age. VA106483 is a non-peptide drug VA106483 that is being developed for the treatment of nocturia in males.
The purpose of this study is to investigate the effect of VA106483 on the number of times the subject needs to get up to urinate (nocturnal void) per night and to determine the effect on the time between the subject's bedtime and the time they first wake up to urinate.
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 |
|---|---|---|
| VA106483 1mg | Experimental | Drug: VA106483 |
| VA106483 2mg | Experimental | Drug: VA106483 |
| VA106483 4mg | Experimental | Drug: VA106483 |
| Sugar pill | Placebo comparator | Drug: VA106483 |
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)
- Male subjects aged ≥18 years (no upper limit) with nocturia
- Generally well (concomitant illness/conditions well controlled)
- Serum sodium within the normal limits
- Normal or not clinically significant prostate specific antigen levels
- Able to comply with the requirements of the study
Key exclusion criteria (15 listed)
- Prostatic cancer
- Signs or symptoms of heart failure
- Peripheral pitting oedema extending ≥10 cm above the ankle
- Palpable bladder or pelvic mass on abdominal examination
- Enuresis or night-time incontinence
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 |
|---|---|---|
| VA106483Drug: VA106483 Once daily oral dose of 1 mg VA106483 or matching placebo for 14 (+3) days. Once daily oral dose of 2 mg VA106483 or matching placebo for 14 (+3) days. Once daily oral dose of 4 mg VA106483 or matching placebo for 28 days. Placebo: as above | Drug | Sugar pill, VA106483 1mg, VA106483 2mg, VA106483 4mg |
Primary outcome
Change in the mean number of nocturnal voids per night
Time frame: 70 days
5 secondary outcomes
Mean duration of first sleep period
Time frame: 70 days
Change in nocturia-related quality of life
Time frame: 70 days
Incidence and frequency of adverse events
Time frame: 70 days
Frequency of hyponatraemia
Time frame: 70 days
Change from baseline in safety laboratory parameters
Time frame: 70 days
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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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.
Mira Baron principal investigator
Rapid Medical Research, Inc.
David Beccia principal investigator
Medical & Clinical Research Associates
Kenneth Blaze principal investigator
South Broward Research, LLC
19 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 VA106483 in people with Nocturia, run by Vantia Ltd at 19 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 15 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 19 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 number of nocturnal voids per night (time frame: 70 days). 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.