Dose Range Finding Study of Fedovapagon in Men With Nocturia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vantia Ltd
ClinicalTrials.gov Identifier:
NCT01656239
First received: July 31, 2012
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to determine the dose level(s) of fedovapagon which result in a decrease in the mean nocturnal void frequency.


Condition Intervention Phase
Nocturia
Drug: fedovapagon 1 mg
Drug: fedovapagon 2 mg
Drug: fedovapagon 4 mg
Drug: Placebo ( sugar pill)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: 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 Range Finding Study To Determine The Efficacy And Safety Of Fedovapagon In Men With Nocturia

Resource links provided by NLM:


Further study details as provided by Vantia Ltd:

Primary Outcome Measures:
  • Change in the mean nocturnal urine voids [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in the mean nocturnal urine voids [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in the mean time to first nocturnal void [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in the mean time to first nocturnal void [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Nocturia-related quality of life (N-QOL) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in Nocturia-related quality of life (N-QOL) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 358
Study Start Date: August 2012
Study Completion Date: September 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fedovapagon 1 mg
Once daily oral dose of 1 mg fedovapagon for 12 weeks
Drug: fedovapagon 1 mg
Experimental: fedovapagon 2 mg
Once daily oral dose of 2 mg fedovapagon for 12 weeks
Drug: fedovapagon 2 mg
Experimental: fedovapagon 4 mg
Once daily oral dose of 4 mg fedovapagon for 12 weeks
Drug: fedovapagon 4 mg
Placebo Comparator: sugar pill
Once daily oral dose of placebo for 12 weeks
Drug: Placebo ( sugar pill)

Detailed Description:

Fedovapagon is a selective vasopressin V2 receptor (V2 receptor) agonist that is being developed for the treatment of Nocturia.

The antidiuretic effect of V2 receptor stimulation in the kidneys is well established through the use of the peptide agonist, desmopressin, which shows clinical benefit in diabetes insipidus, primary nocturnal enuresis and Nocturia.

Nocturia, defined as the complaint that the individual has to wake at night one or more times to void, is a common complaint and shows an age-dependent increase in both prevalence and severity (number of Nocturnal Voids). It is the most bothersome symptom of benign prostatic hypertrophy (BPH) and has been linked to an age-dependent loss in circadian release of endogenous nocturnal vasopressin and consequent over production of urine at night (Nocturnal Polyuria).

The purpose of this Phase IIb study is to determine the efficacy of different doses of fedovapagon in reducing the number of times subjects with Nocturia void during the night together with other parameters including increasing the time between going to bed and waking to first void. By establishing the effective doses of fedovapagon on these clinical endpoints, the data from this study will determine the most appropriate dose(s) of fedovapagon for the treatment of Nocturia to be taken forward into further studies.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males aged 55 or over
  • History and/ or symptoms of Nocturia (2 - 5 voids per night)
  • Generally well (concomitant illness / conditions well controlled)
  • Serum sodium, potassium, chloride and bicarbonate within normal limits
  • No clinically significant abnormalities in other laboratory parameters, urinalysis, electrocardiogram (ECG) or physical examination
  • Prostate specific antigen (PSA) within the normal range or not considered clinically significant
  • Ability to comply with the requirements of the study
  • Written informed consent.

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656239

  Show 56 Study Locations
Sponsors and Collaborators
Vantia Ltd
Investigators
Study Director: Hilary McElwaine-Johnn, BSc, ASM, MBBS, MRCP, MFPM Vantia Ltd
  More Information

No publications provided

Responsible Party: Vantia Ltd
ClinicalTrials.gov Identifier: NCT01656239     History of Changes
Other Study ID Numbers: 483-009
Study First Received: July 31, 2012
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Vantia Ltd:
VA106483, fedovapagon, Nocturia, males, nocturnal voids, anti-diuretic

Additional relevant MeSH terms:
Nocturia
Lower Urinary Tract Symptoms
Signs and Symptoms
Urological Manifestations

ClinicalTrials.gov processed this record on October 29, 2014