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Dose Response Study of VA106483 in Males With Nocturia and Benign Prostatic Hypertrophy (BPH)

This study has been completed.
Sponsor:
Information provided by:
Vantia Ltd
ClinicalTrials.gov Identifier:
NCT01330927
First received: March 30, 2011
Last updated: August 1, 2011
Last verified: August 2011

March 30, 2011
August 1, 2011
March 2011
July 2011   (final data collection date for primary outcome measure)
Change in the mean nocturnal urine volumes [ Time Frame: 20 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01330927 on ClinicalTrials.gov Archive Site
  • Change in the mean nocturnal void frequency [ Time Frame: 20 days ] [ Designated as safety issue: No ]
  • Change in mean time to first void [ Time Frame: 20 days ] [ Designated as safety issue: No ]
  • Change in frequency of daytime voids [ Time Frame: 20 days ] [ Designated as safety issue: No ]
  • Change in mean volume of daytime voids [ Time Frame: 20 days ] [ Designated as safety issue: No ]
  • Change in mean nocturnal urine osmolality [ Time Frame: 20 days ] [ Designated as safety issue: No ]
  • Change in mean daytime urine osmolality [ Time Frame: 20 days ] [ Designated as safety issue: No ]
  • Change in mean voided volumes [ Time Frame: 20 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dose Response Study of VA106483 in Males With Nocturia and Benign Prostatic Hypertrophy (BPH)
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Nocturia
  • Benign Prostatic Hypertrophy (BPH)
Drug: 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

  • Experimental: VA106483 0.5 mg
    Intervention: Drug: VA106483
  • Experimental: VA106483 1 mg
    Intervention: Drug: VA106483
  • Experimental: VA106483 2 mg
    Intervention: Drug: VA106483
  • Experimental: VA106483 4 mg
    Intervention: Drug: VA106483
  • Placebo Comparator: Sugar pill
    Intervention: Drug: VA106483
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males aged 65 years old and above with history of nocturia and benign prostatic hypertrophy (BPH)

Exclusion Criteria:

  • 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
Male
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01330927
483-008
No
Dr Hilary McElwaine-Johnn / Chief Medical Officer, Vantia Ltd, 1 Venture Road, Southampton Science Park, Southampton, SO16 7NP, UK
Vantia Ltd
Not Provided
Principal Investigator: Georg Golor, PD Dr. med. PAREXEL International GmbH
Vantia Ltd
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP