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Efficacy Study of VA106483 in Males With Nocturia.

V

Vantia

Status and phase

Completed
Phase 2

Conditions

Nocturia

Treatments

Drug: VA106483

Study type

Interventional

Funder types

Industry

Identifiers

NCT01038843
483-005

Details and patient eligibility

About

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

Full 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.

Enrollment

152 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

152 participants in 4 patient groups, including a placebo group

VA106483 1mg
Experimental group
Treatment:
Drug: VA106483
VA106483 2mg
Experimental group
Treatment:
Drug: VA106483
VA106483 4mg
Experimental group
Treatment:
Drug: VA106483
Sugar pill
Placebo Comparator group
Treatment:
Drug: VA106483

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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