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)
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 30, 2011
CompletedFirst Posted
Study publicly available on registry
April 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedAugust 2, 2011
August 1, 2011
4 months
March 30, 2011
August 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the mean nocturnal urine volumes
20 days
Secondary Outcomes (7)
Change in the mean nocturnal void frequency
20 days
Change in mean time to first void
20 days
Change in frequency of daytime voids
20 days
Change in mean volume of daytime voids
20 days
Change in mean nocturnal urine osmolality
20 days
- +2 more secondary outcomes
Study Arms (5)
VA106483 0.5 mg
EXPERIMENTALVA106483 1 mg
EXPERIMENTALVA106483 2 mg
EXPERIMENTALVA106483 4 mg
EXPERIMENTALSugar pill
PLACEBO COMPARATORInterventions
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
You may qualify if:
- Males aged 65 years old and above with history of nocturia and benign prostatic hypertrophy (BPH)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vantia Ltdlead
Study Sites (1)
Early Phase Clinical Unit, PAREXEL International GmbH
Berlin, 14050, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Georg Golor, PD Dr. med.
Parexel
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 30, 2011
First Posted
April 7, 2011
Study Start
March 1, 2011
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
August 2, 2011
Record last verified: 2011-08