Efficacy Study of VA106483 in Males With Nocturia.

Nocturia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01038843
• Other study ID #: 483-005
• Status: Completed
• Phase: Phase 2
• First received: December 22, 2009
• Last updated: June 18, 2014
• Start date: December 2009
• Est. completion date: August 2010

Study information

• Verified date: June 2014
• Source: Vantia Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To investigate the effect of VA106483 on nocturia related clinical outcomes compared to placebo.

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 information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nocturia

Intervention

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

Locations

Country	Name	City	State
United States	Urology Associates of North Texas	Arlington	Texas
United States	The Urology Team P.A.	Austin	Texas
United States	South Florida Medical Research	Aventura	Florida
United States	Medical & Clinical Research Associates	Bayshore	New York
United States	Parkhurst Research Organization	Bethany	Oklahoma
United States	Alabama Research Center, LLC	Birmingham	Alabama
United States	Discovery Clinical Trials	Celebration	Florida
United States	Rapid Medical Research, Inc.	Clevland	Ohio
United States	Avail Clinical Research LLC	DeLand	Florida
United States	Accumed Research Associates	Garden City	New York
United States	Urology Center of Florida	Hialeah	Florida
United States	Tower Urology Medical Group	Los Angeles	California
United States	Grove Hill Clinical Research	New Britian	Connecticut
United States	South Broward Research, LLC	Pembroke Pines	Florida
United States	Hudson Valley Urology, PC	Poughkeepsie	New York
United States	Health Texas Research Institute	San Antonio	Texas
United States	Martin Diagnostic Clinic	Tomball	Texas
United States	Genova Clinical Research	Tucson	Arizona
United States	Bay State Clinical Trials, Inc.	Watertown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Vantia Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the mean number of nocturnal voids per night		70 days	No
Secondary	Mean duration of first sleep period		70 days	No
Secondary	Change in nocturia-related quality of life		70 days	No
Secondary	Incidence and frequency of adverse events		70 days	Yes
Secondary	Frequency of hyponatraemia		70 days	Yes
Secondary	Change from baseline in safety laboratory parameters		70 days	Yes