Efficacy Study of VA106483 in Males With Nocturia.
This study has been completed.
Sponsor:
Vantia Ltd
Information provided by:
Vantia Ltd
ClinicalTrials.gov Identifier:
NCT01038843
First received: December 22, 2009
Last updated: September 7, 2010
Last verified: September 2010
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Purpose
To investigate the effect of VA106483 on nocturia related clinical outcomes compared to placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Nocturia |
Drug: VA106483 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-titration Study to Determine the Efficacy and Safety of VA106483 in Male Subjects With Nocturia |
Further study details as provided by Vantia Ltd:
Primary Outcome Measures:
- Change in the mean number of nocturnal voids per night [ Time Frame: 70 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mean duration of first sleep period [ Time Frame: 70 days ] [ Designated as safety issue: No ]
- Change in nocturia-related quality of life [ Time Frame: 70 days ] [ Designated as safety issue: No ]
- Incidence and frequency of adverse events [ Time Frame: 70 days ] [ Designated as safety issue: Yes ]
- Frequency of hyponatraemia [ Time Frame: 70 days ] [ Designated as safety issue: Yes ]
- Change from baseline in safety laboratory parameters [ Time Frame: 70 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 152 |
| Study Start Date: | December 2009 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: VA106483 1mg |
Drug: VA106483
Drug: VA106483 Once daily oral dose of 1 mg VA106483 or matching placebo for 14 (+3) days. Once daily oral dose of 2 mg VA106483 or matching placebo for 14 (+3) days. Once daily oral dose of 4 mg VA106483 or matching placebo for 28 days. Placebo: as above |
| Experimental: VA106483 2mg |
Drug: VA106483
Drug: VA106483 Once daily oral dose of 1 mg VA106483 or matching placebo for 14 (+3) days. Once daily oral dose of 2 mg VA106483 or matching placebo for 14 (+3) days. Once daily oral dose of 4 mg VA106483 or matching placebo for 28 days. Placebo: as above |
| Experimental: VA106483 4mg |
Drug: VA106483
Drug: VA106483 Once daily oral dose of 1 mg VA106483 or matching placebo for 14 (+3) days. Once daily oral dose of 2 mg VA106483 or matching placebo for 14 (+3) days. Once daily oral dose of 4 mg VA106483 or matching placebo for 28 days. Placebo: as above |
| Placebo Comparator: Sugar pill |
Drug: VA106483
Drug: VA106483 Once daily oral dose of 1 mg VA106483 or matching placebo for 14 (+3) days. Once daily oral dose of 2 mg VA106483 or matching placebo for 14 (+3) days. Once daily oral dose of 4 mg VA106483 or matching placebo for 28 days. Placebo: as above |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038843
Locations
| United States, Alabama | |
| Alabama Research Center, LLC | |
| Birmingham, Alabama, United States, 35209 | |
| United States, Arizona | |
| Genova Clinical Research | |
| Tucson, Arizona, United States, 85741 | |
| United States, California | |
| Tower Urology Medical Group | |
| Los Angeles, California, United States, 90048 | |
| United States, Connecticut | |
| Grove Hill Clinical Research | |
| New Britian, Connecticut, United States, 06052 | |
| United States, Florida | |
| South Florida Medical Research | |
| Aventura, Florida, United States, 33180 | |
| Discovery Clinical Trials | |
| Celebration, Florida, United States, 34747 | |
| Avail Clinical Research LLC | |
| DeLand, Florida, United States, 32720 | |
| Urology Center of Florida | |
| Hialeah, Florida, United States, 33012 | |
| South Broward Research, LLC | |
| Pembroke Pines, Florida, United States, 33027 | |
| United States, Massachusetts | |
| Bay State Clinical Trials, Inc. | |
| Watertown, Massachusetts, United States, 02472 | |
| United States, New York | |
| Medical & Clinical Research Associates | |
| Bayshore, New York, United States, 11706 | |
| Accumed Research Associates | |
| Garden City, New York, United States, 11530 | |
| Hudson Valley Urology, PC | |
| Poughkeepsie, New York, United States, 12601 | |
| United States, Ohio | |
| Rapid Medical Research, Inc. | |
| Clevland, Ohio, United States, 44122 | |
| United States, Oklahoma | |
| Parkhurst Research Organization | |
| Bethany, Oklahoma, United States, 73008 | |
| United States, Texas | |
| Urology Associates of North Texas | |
| Arlington, Texas, United States, 76017 | |
| The Urology Team P.A. | |
| Austin, Texas, United States, 78759 | |
| Health Texas Research Institute | |
| San Antonio, Texas, United States, 78212 | |
| Martin Diagnostic Clinic | |
| Tomball, Texas, United States, 77375 | |
Sponsors and Collaborators
Vantia Ltd
Investigators
| Principal Investigator: | Mira Baron | Rapid Medical Research, Inc. |
| Principal Investigator: | David Beccia | Medical & Clinical Research Associates |
| Principal Investigator: | Kenneth Blaze | South Broward Research, LLC |
| Principal Investigator: | Mitchell Efros | Accumed Research Associates |
| Principal Investigator: | Marc Gittelman | South Florida Medical Research |
| Principal Investigator: | Evan Goldfischer | Hudson Valley Urology, PC |
| Principal Investigator: | Elizabeth Houser | The Urology Team P.A. |
| Principal Investigator: | Theodore Johnson II | Emory University |
| Principal Investigator: | Steven Kester | Urology Center of Florida |
| Principal Investigator: | Richard Lotenfoe | Discovery Clinical Trials |
| Principal Investigator: | Earl Martin | Martin Diagnostic Clinic |
| Principal Investigator: | H. David Mitcheson | Bay State Clinical Trials, Inc. |
| Principal Investigator: | Chris Ng | Tower Urology Medical Group |
| Principal Investigator: | Aris Nikas | Health Texas Research Institute |
| Principal Investigator: | Joseph Parkhurst | Parkhurst Research Organization |
| Principal Investigator: | Bruce Rankin | Avail Clinical Research LLC |
| Principal Investigator: | Leah Schmidt | Genova Clinical Research |
| Principal Investigator: | Howard Hezmall | Urology Associates of North Texas |
| Principal Investigator: | Wilbur Wells Jnr | Alabama Research Center, LLC |
| Principal Investigator: | Rafael Wurzel | Grove Hill Clinical Research |
More Information
No publications provided
| Responsible Party: | Dr Robert Tansley / Interim Medical Officer, Vantia Ltd, 1 Venture Road, Southampton Science Park, Southampton SO16 7NP |
| ClinicalTrials.gov Identifier: | NCT01038843 History of Changes |
| Other Study ID Numbers: | 483-005 |
| Study First Received: | December 22, 2009 |
| Last Updated: | September 7, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Vantia Ltd:
|
VA106483 Nocturia males |
nocturnal voids anti-diuretic hyponatraemia |
Additional relevant MeSH terms:
|
Nocturia Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013