NocturiaPhase 1NCT01330927
Dose Response Study of VA106483 in Males With Nocturia and Benign Prostatic Hypertrophy (BPH)
A Phase 1 study testing VA106483 in people with Nocturia and Benign Prostatic Hypertrophy (BPH), run by Vantia Ltd at 1 site in Germany.
Trial summary
The purpose of this study is to establish the dose response relationship of VA106483 and nocturnal urine volumes in a population of elderly male subjects with Benign Prostatic Hypertrophy (BPH) who are likely to present with nocturia. Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Nocturia, Benign Prostatic Hypertrophy (BPH)
- 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
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Jul 2011
- Phase
- Phase 1
- 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 65 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- Males aged 65 years old and above with history of nocturia and benign prostatic hypertrophy (BPH)
Who cannot join
- Administration of any Investigational Medicinal Product (IMP) within 10 weeks before entry to the study
- Any clinically significant concomitant medical disease, condition or abnormal laboratory test result
- Other protocol defined eligibility criteria may apply
Trial locations and contacts
1 site in 1 country.
Germany1 site
Early Phase Clinical Unit, PAREXEL International GmbH
Berlin, 14050
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Five-way Cross-over Dose Response Study to Determine the Effect of VA106483 on Nocturnal Urine Volume in Elderly Male Subjects With Nocturia and Benign Prostatic Hypertrophy (BPH)
The purpose of this study is to establish the dose response relationship of VA106483 and nocturnal urine volumes in a population of elderly male subjects with Benign Prostatic Hypertrophy (BPH) who are likely to present with nocturia.
Read the detailed description
VA106483 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 waking to void at least once per night between periods of sleep, 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 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).
Correlation between nocturnal urine volume and nocturnal void frequency has been demonstrated in previous studies of V2-receptor agonists.
The purpose of this study is to determine the dose response relationship of VA106483 and nocturnal urine volumes.
- Conditions
- Nocturia, Benign Prostatic Hypertrophy (BPH)
- Being tested
- VA106483
- Keywords
- VA106483, Nocturia, Benign Prostatic Hypertrophy, BPH, Elderly, Males, Nocturnal voids, Anti-diuretic
- 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.
VA106483Drug
Once daily oral dose of placebo for 2 nights
Once daily oral dose of 0.5 mg VA106483 for 2 nights
Once daily oral dose of 1 mg VA106483 for 2 nights
Once daily oral dose of 2 mg VA106483 for 2 nights
Once daily oral dose of 4 mg VA106483 for 2 nights
Placebo: as above
| Study group | Role | What they receive |
|---|---|---|
| VA106483 0.5 mg | Experimental | Not described Receives: Drug: VA106483 |
| VA106483 1 mg | Experimental | Not described Receives: Drug: VA106483 |
| VA106483 2 mg | Experimental | Not described Receives: Drug: VA106483 |
| VA106483 4 mg | 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 nocturnal urine volumes
Measured: 20 days
Secondary outcomes (7)
Change in the mean nocturnal void frequency
Measured: 20 days
Change in mean time to first void
Measured: 20 days
Change in frequency of daytime voids
Measured: 20 days
Change in mean volume of daytime voids
Measured: 20 days
Change in mean nocturnal urine osmolality
Measured: 20 days
Change in mean daytime urine osmolality
Measured: 20 days
Change in mean voided volumes
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2011
- Study completionJul 2011
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantia Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Georg Golor, PD Dr. med., Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330927
- Sponsor's protocol ID
- 483-008
- Status last verified
- Aug 2011
- First submitted
- 30 Mar 2011
- Last updated
- 2 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Five-way Cross-over Dose Response Study to Determine the Effect of VA106483 on Nocturnal Urine Volume in Elderly Male Subjects With Nocturia and Benign Prostatic Hypertrophy (BPH)
- ClinicalTrials.gov ID
- NCT01330927
- Acronym / sponsor ID
- 483-008
- Conditions
- Nocturia, Benign Prostatic Hypertrophy (BPH)
- Keywords
- VA106483, Nocturia, Benign Prostatic Hypertrophy, BPH, Elderly, Males, Nocturnal voids, Anti-diuretic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vantia LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 7 Apr 2011 (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 establish the dose response relationship of VA106483 and nocturnal urine volumes in a population of elderly male subjects with Benign Prostatic Hypertrophy (BPH) who are likely to present with nocturia.
Detailed description
VA106483 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 waking to void at least once per night between periods of sleep, 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 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).
Correlation between nocturnal urine volume and nocturnal void frequency has been demonstrated in previous studies of V2-receptor agonists.
The purpose of this study is to determine the dose response relationship of VA106483 and nocturnal urine volumes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| VA106483 0.5 mg | Experimental | Drug: VA106483 |
| VA106483 1 mg | Experimental | Drug: VA106483 |
| VA106483 2 mg | Experimental | Drug: VA106483 |
| VA106483 4 mg | Experimental | Drug: VA106483 |
| Sugar pill | Placebo comparator | Drug: VA106483 |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Males aged 65 years old and above with history of nocturia and benign prostatic hypertrophy (BPH)
Key exclusion criteria (3 listed)
- Administration of any Investigational Medicinal Product (IMP) within 10 weeks before entry to the study
- Any clinically significant concomitant medical disease, condition or abnormal laboratory test result
- Other protocol defined eligibility criteria may apply
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 |
|---|---|---|
| VA106483Once daily oral dose of placebo for 2 nights Once daily oral dose of 0.5 mg VA106483 for 2 nights Once daily oral dose of 1 mg VA106483 for 2 nights Once daily oral dose of 2 mg VA106483 for 2 nights Once daily oral dose of 4 mg VA106483 for 2 nights Placebo: as above | Drug | Sugar pill, VA106483 0.5 mg, VA106483 1 mg, VA106483 2 mg, VA106483 4 mg |
Primary outcome
Change in the mean nocturnal urine volumes
Time frame: 20 days
7 secondary outcomes
Change in the mean nocturnal void frequency
Time frame: 20 days
Change in mean time to first void
Time frame: 20 days
Change in frequency of daytime voids
Time frame: 20 days
Change in mean volume of daytime voids
Time frame: 20 days
Change in mean nocturnal urine osmolality
Time frame: 20 days
Change in mean daytime urine osmolality
Time frame: 20 days
Change in mean voided volumes
Time frame: 20 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 2 Aug 2011.
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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.
Georg Golor, PD Dr. med. principal investigator
Parexel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VA106483 in people with Nocturia and Benign Prostatic Hypertrophy (BPH), run by Vantia Ltd at 1 site in Germany.
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 1 inclusion and 3 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 2 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 volumes (time frame: 20 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 2 Aug 2011.