NCT00879138

Brief Summary

A double blind, placebo-controlled, dose ranging study in males over the age of 65, who have a history of nocturia. The study will investigate pharmacodynamic outcomes (urine volumes and osmolality, circulating coagulation factors and haemodynamics) and pharmacokinetics, of both single and multiple oral doses of VA106483 at three dose levels, under conditions of controlled hydration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2009

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 9, 2009

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

February 18, 2009

Last Update Submit

October 29, 2018

Conditions

Nocturia

Outcome Measures

Primary Outcomes (1)

  • Pharmacodynamic profile of VA106483

Secondary Outcomes (2)

  • Pharmacokinetic profile of VA106483

  • Safety and tolerability of VA106483

Study Arms (4)

Sugar pill

PLACEBO COMPARATOR
Drug: Sugar pill

VA106483 2 mg

EXPERIMENTAL
Drug: VA106483

VA106483 4 mg

EXPERIMENTAL
Drug: VA106483

VA106483 8 mg

EXPERIMENTAL
Drug: VA106483

Interventions

VA106483DRUG
VA106483 2 mgVA106483 4 mgVA106483 8 mg
Sugar pillDRUG
Sugar pill

Eligibility Criteria

Age65 Years+
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Males 65 years and above with history of nocturia

You may not qualify if:

  • Any clinically significant concomitant medical disease, condition or abnormal laboratory test result
  • Participation in any other clinical study within 30 days
  • Intake of non-prescription medication within 14 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veeda Clinical Research

Plymouth, United Kingdom

Location

MeSH Terms

Conditions

Nocturia

Interventions

Sugars

Condition Hierarchy (Ancestors)

Lower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2009

First Posted

April 9, 2009

Study Start

August 1, 2008

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

October 31, 2018

Record last verified: 2018-10

Locations

GB(1)