Dose Response Study of VA106483 in Males With Nocturia and Benign Prostatic Hypertrophy (BPH)
NCT ID: NCT01330927
Last Updated: 2011-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2011-03-31
2011-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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VA106483 0.5 mg
VA106483
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
VA106483 1 mg
VA106483
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
VA106483 2 mg
VA106483
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
VA106483 4 mg
VA106483
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
Sugar pill
VA106483
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
Interventions
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VA106483
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any clinically significant concomitant medical disease, condition or abnormal laboratory test result
* Other protocol defined eligibility criteria may apply
65 Years
MALE
No
Sponsors
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Vantia Ltd
INDUSTRY
Responsible Party
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Vantia Ltd, 1 Venture Road, Southampton Science Park, Southampton, SO16 7NP, UK
Principal Investigators
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Georg Golor, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Parexel
Locations
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Early Phase Clinical Unit, PAREXEL International GmbH
Berlin, , Germany
Countries
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Other Identifiers
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483-008
Identifier Type: -
Identifier Source: org_study_id
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