NocturiaPhase 1NCT00922740
VA106483 Dose Response Study in Elderly Males
A Phase 1 study testing VA106483 in people with Nocturia, run by Vantia Ltd at 1 site in United States.
Trial summary
The main purpose of the study is to evaluate the way VA106483 enters and leaves the blood and tissues over time and how the drug acts on and in the body at various dose levels compared to placebo in the same volunteer. Read more about this study
- Who is it for?
- Ages 65 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nocturia
- What is being tested?
- VA106483
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Sep 2009
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male, Age: 65 years and above
- Using adequate contraception
- Medical history without clinically significant pathologies; no evidence of serious pathology or disease
- Physical examination parameters without signs of serious disease
- No clinically significant ECG and lab safety tests (sodium must be within normal range)
- Willing and able to participate and provides written informed consent
Who cannot join
- Cardiac insufficiency; signs or symptoms suggestive of heart failure or requiring treatment with diuretics
- Supine arterial blood pressure higher than 170/100 mmHg or less than 105/60 mm Hg
- Presence of poorly controlled endocrine disorders
- Renal insufficiency, active hepatic and/or biliary disease
- Hyponatraemia. Serum sodium level must be within normal limits
- Syndrome of inappropriate antidiuretic hormone (ADH) secretion
Show all 13Show fewer
- Symptoms suggestive of psychogenic or habitual polydipsia or of diabetes insipidus
- Known hypersensitivity to the IP or any constituent of the IP
- Use of any non-prescription preparation within 72 hours prior to study entry, with the exception of defined pain killers
- A history of alcohol abuse or drug addiction within the last 2 years
- Positive screen for HIV, hepatitis B or C
- Currently taking any diuretics or any concomitant medication known to be a cytochrome 3A4 inhibitor
- Other protocol defined eligibility criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Quintiles Phase I Services
Overland Park, Kansas, 66211
About this study
Official title: An Open Label, Escalation Study to Assess Intra-Subject Dose Response to VA106483 in Elderly Male Subjects
The main purpose of the study is to evaluate the way VA106483 enters and leaves the blood and tissues over time and how the drug acts on and in the body at various dose levels compared to placebo in the same volunteer.
Read the detailed description
VA106483 is intended to be used as a treatment for patients suffering from nocturia (defined as waking to urinate at least once per night between periods of sleep). Nocturia is a condition that often worsens as sufferers get older. This may be due to an over-active bladder muscle, the bladder being able to hold less urine at night-time or over production of urine in the bladder at night.
The only antidiuretic approved for the treatment (in some countries) of nocturia is the peptide drug, desmopressin. However, as it can cause hyponatraemia in a proportion of patients above the age of 65 years it is contra-indicated in the elderly. This side-effect has not been observed with VA106483, making it potentially suitable for treating the elderly. The purpose of this study is to confirm that duration of action of VA106483 can be effectively controlled by dose and therefore that satisfactory clinical outcome in the treatment of nocturia can be achieved by individual dose titration.
Subjects will be water-loaded, dosed with either VA106483 or placebo and then urine production will be monitored to assess any anti-diuretic effect.
- Conditions
- Nocturia
- Being tested
- VA106483, Placebo
- Keywords
- Nocturia, Pharmacokinetics, Pharmacodynamics, Water-loading, Elderly, Males
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VA106483Drug
Placebo on Day 1, 1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7
PlaceboDrug
Placebo on Day 1, 1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill | Placebo comparator | Not described Receives: Drug: Placebo |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine volume and osmolality and plasma PK assessments
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2009
- Study completionSep 2009
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantia Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralph Schutz, Principal investigator, Quintiles Phase I Services, Overland Park, KS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922740
- Sponsor's protocol ID
- 483-002
- Status last verified
- May 2018
- First submitted
- 10 Jun 2009
- Last updated
- 23 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Escalation Study to Assess Intra-Subject Dose Response to VA106483 in Elderly Male Subjects
- ClinicalTrials.gov ID
- NCT00922740
- Acronym / sponsor ID
- 483-002
- Conditions
- Nocturia
- Keywords
- Nocturia, Pharmacokinetics, Pharmacodynamics, Water-loading, Elderly, Males
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vantia LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 17 Jun 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.
The main purpose of the study is to evaluate the way VA106483 enters and leaves the blood and tissues over time and how the drug acts on and in the body at various dose levels compared to placebo in the same volunteer.
Detailed description
VA106483 is intended to be used as a treatment for patients suffering from nocturia (defined as waking to urinate at least once per night between periods of sleep). Nocturia is a condition that often worsens as sufferers get older. This may be due to an over-active bladder muscle, the bladder being able to hold less urine at night-time or over production of urine in the bladder at night.
The only antidiuretic approved for the treatment (in some countries) of nocturia is the peptide drug, desmopressin. However, as it can cause hyponatraemia in a proportion of patients above the age of 65 years it is contra-indicated in the elderly. This side-effect has not been observed with VA106483, making it potentially suitable for treating the elderly. The purpose of this study is to confirm that duration of action of VA106483 can be effectively controlled by dose and therefore that satisfactory clinical outcome in the treatment of nocturia can be achieved by individual dose titration.
Subjects will be water-loaded, dosed with either VA106483 or placebo and then urine production will be monitored to assess any anti-diuretic effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sugar pill | Placebo comparator | Drug: Placebo |
| VA106483 1 mg | Experimental | Drug: VA106483 |
| VA106483 2 mg | Experimental | Drug: VA106483 |
| VA106483 4 mg | Experimental | Drug: VA106483 |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Male, Age: 65 years and above
- Using adequate contraception
- Medical history without clinically significant pathologies; no evidence of serious pathology or disease
- Physical examination parameters without signs of serious disease
- No clinically significant ECG and lab safety tests (sodium must be within normal range)
Key exclusion criteria (13 listed)
- Cardiac insufficiency; signs or symptoms suggestive of heart failure or requiring treatment with diuretics
- Supine arterial blood pressure higher than 170/100 mmHg or less than 105/60 mm Hg
- Presence of poorly controlled endocrine disorders
- Renal insufficiency, active hepatic and/or biliary disease
- Hyponatraemia. Serum sodium level must be within normal limits
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 |
|---|---|---|
| VA106483Placebo on Day 1, 1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7 | Drug | VA106483 1 mg, VA106483 2 mg, VA106483 4 mg |
| PlaceboPlacebo on Day 1, 1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7 | Drug | Sugar pill |
Primary outcome
Urine volume and osmolality and plasma PK assessments
Time frame: 24 Hours
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 23 May 2018.
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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.
Ralph Schutz principal investigator
Quintiles Phase I Services, Overland Park, KS
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, run by Vantia Ltd at 1 site 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 13 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 23 May 2018. 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 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 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?
Urine volume and osmolality and plasma PK assessments (time frame: 24 Hours). 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 23 May 2018.