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
  Purpose

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.


Condition Intervention Phase
Nocturia
Benign Prostatic Hypertrophy (BPH)
Drug: VA106483
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Vantia Ltd:

Primary Outcome Measures:
  • Change in the mean nocturnal urine volumes [ Time Frame: 20 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: March 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VA106483 0.5 mg 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 1 mg 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 2 mg 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 4 mg 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

Placebo Comparator: Sugar pill 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


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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330927

Locations
Germany
Early Phase Clinical Unit, PAREXEL International GmbH
Berlin, Germany, 14050
Sponsors and Collaborators
Vantia Ltd
Investigators
Principal Investigator: Georg Golor, PD Dr. med. PAREXEL International GmbH
  More Information

No publications provided

Responsible Party: Dr Hilary McElwaine-Johnn / Chief Medical Officer, Vantia Ltd, 1 Venture Road, Southampton Science Park, Southampton, SO16 7NP, UK
ClinicalTrials.gov Identifier: NCT01330927     History of Changes
Other Study ID Numbers: 483-008
Study First Received: March 30, 2011
Last Updated: August 1, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Vantia Ltd:
VA106483
Nocturia
Benign Prostatic Hypertrophy
BPH
Elderly
Males
Nocturnal voids
Anti-diuretic

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hypertrophy
Nocturia
Prostatic Diseases
Genital Diseases, Male
Pathological Conditions, Anatomical
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014