Efficacy Study of VA106483 in Males With Nocturia.

NCT01038843 | Completed Phase 2

• 1 other identifier: 483-005
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 19

Brief Summary

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

Conditions

Nocturia

Keywords

VA106483; Nocturia; males; nocturnal voids; anti-diuretic; hyponatraemia

Outcome Measures

Primary Outcomes (1)

• Change in the mean number of nocturnal voids per night

  70 days

Secondary Outcomes (5)

• 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

Study Arms (4)

VA106483 1mg

EXPERIMENTAL

Drug: VA106483

VA106483 2mg

EXPERIMENTAL

Drug: VA106483

VA106483 4mg

EXPERIMENTAL

Drug: VA106483

Sugar pill

PLACEBO COMPARATOR

Drug: VA106483

Interventions

VA106483 DRUG

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

Sugar pill; VA106483 1mg; VA106483 2mg; VA106483 4mg

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vantia Ltd: lead

Study Sites (19)

Alabama Research Center, LLC

Birmingham, Alabama, 35209, United States

Location

Genova Clinical Research

Tucson, Arizona, 85741, United States

Location

Tower Urology Medical Group

Los Angeles, California, 90048, United States

Location

Grove Hill Clinical Research

New Britian, Connecticut, 06052, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

Discovery Clinical Trials

Celebration, Florida, 34747, United States

Location

Avail Clinical Research LLC

DeLand, Florida, 32720, United States

Location

Urology Center of Florida

Hialeah, Florida, 33012, United States

Location

South Broward Research, LLC

Pembroke Pines, Florida, 33027, United States

Location

Bay State Clinical Trials, Inc.

Watertown, Massachusetts, 02472, United States

Location

Medical & Clinical Research Associates

Bay Shore, New York, 11706, United States

Location

Accumed Research Associates

Garden City, New York, 11530, United States

Location

Hudson Valley Urology, PC

Poughkeepsie, New York, 12601, United States

Location

Rapid Medical Research, Inc.

Clevland, Ohio, 44122, United States

Location

Parkhurst Research Organization

Bethany, Oklahoma, 73008, United States

Location

Urology Associates of North Texas

Arlington, Texas, 76017, United States

Location

The Urology Team P.A.

Austin, Texas, 78759, United States

Location

Health Texas Research Institute

San Antonio, Texas, 78212, United States

Location

Martin Diagnostic Clinic

Tomball, Texas, 77375, United States

Location

MeSH Terms

Conditions

Nocturia; Hyponatremia

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 24, 2009
• Study Start: December 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: June 20, 2014

Record last verified: 2014-06

Locations

US (19)