Efficacy Study of VA106483 in Males With Nocturia.
- Registration Number
- NCT01038843
- Lead Sponsor
- Vantia Ltd
- Brief Summary
To investigate the effect of VA106483 on nocturia related clinical outcomes compared to placebo.
- Detailed Description
Nocturia, defined as waking to urinate at least once per night between periods of sleep, is a common complaint which increases with age. VA106483 is a non-peptide drug VA106483 that is being developed for the treatment of nocturia in males.
The purpose of this study is to investigate the effect of VA106483 on the number of times the subject needs to get up to urinate (nocturnal void) per night and to determine the effect on the time between the subject's bedtime and the time they first wake up to urinate.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 152
- Male subjects aged ≥18 years (no upper limit) with nocturia
- Generally well (concomitant illness/conditions well controlled)
- Serum sodium within the normal limits
- Normal or not clinically significant prostate specific antigen levels
- Able to comply with the requirements of the study
- Provide written informed consent
- Prostatic cancer
- Signs or symptoms of heart failure
- Peripheral pitting oedema extending ≥10 cm above the ankle
- Palpable bladder or pelvic mass on abdominal examination
- Enuresis or night-time incontinence
- Excessive nocturnal void frequency
- Sleep disorders
- Diabetes insipidus or uncontrolled diabetes mellitus
- Presence of blood or glucose in the urine on urinalysis that is clinically significant
- Urinary tract infection
- Polydipsia
- Syndrome of inappropriate antidiuretic hormone secretion
- Body mass index ≥35
- High calcium levels or low potassium levels
- Other protocol defined eligibility criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VA106483 1mg VA106483 - VA106483 2mg VA106483 - VA106483 4mg VA106483 - Sugar pill VA106483 -
- Primary Outcome Measures
Name Time Method Change in the mean number of nocturnal voids per night 70 days
- Secondary Outcome Measures
Name Time Method Mean duration of first sleep period 70 days Change in nocturia-related quality of life 70 days Incidence and frequency of adverse events 70 days Frequency of hyponatraemia 70 days Change from baseline in safety laboratory parameters 70 days
Trial Locations
- Locations (19)
Grove Hill Clinical Research
🇺🇸New Britian, Connecticut, United States
Genova Clinical Research
🇺🇸Tucson, Arizona, United States
Discovery Clinical Trials
🇺🇸Celebration, Florida, United States
Avail Clinical Research LLC
🇺🇸DeLand, Florida, United States
Bay State Clinical Trials, Inc.
🇺🇸Watertown, Massachusetts, United States
Hudson Valley Urology, PC
🇺🇸Poughkeepsie, New York, United States
Rapid Medical Research, Inc.
🇺🇸Clevland, Ohio, United States
Parkhurst Research Organization
🇺🇸Bethany, Oklahoma, United States
Medical & Clinical Research Associates
🇺🇸Bayshore, New York, United States
Accumed Research Associates
🇺🇸Garden City, New York, United States
Alabama Research Center, LLC
🇺🇸Birmingham, Alabama, United States
The Urology Team P.A.
🇺🇸Austin, Texas, United States
Tower Urology Medical Group
🇺🇸Los Angeles, California, United States
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Urology Associates of North Texas
🇺🇸Arlington, Texas, United States
Martin Diagnostic Clinic
🇺🇸Tomball, Texas, United States
Urology Center of Florida
🇺🇸Hialeah, Florida, United States
South Broward Research, LLC
🇺🇸Pembroke Pines, Florida, United States
Health Texas Research Institute
🇺🇸San Antonio, Texas, United States