Dose Range Finding Study of Fedovapagon in Men With Nocturia
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|ClinicalTrials.gov Identifier: NCT01656239|
Recruitment Status : Completed
First Posted : August 2, 2012
Last Update Posted : June 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Nocturia||Drug: fedovapagon 1 mg Drug: fedovapagon 2 mg Drug: fedovapagon 4 mg Drug: Placebo ( sugar pill)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||358 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||September 2013|
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)
- Change in the mean nocturnal urine voids [ Time Frame: 12 weeks ]
- Change in the mean nocturnal urine voids [ Time Frame: 4 weeks ]
- Change in the mean time to first nocturnal void [ Time Frame: 4 weeks ]
- Change in the mean time to first nocturnal void [ Time Frame: 12 weeks ]
- Change in Nocturia-related quality of life (N-QOL) [ Time Frame: 4 weeks ]
- Change in Nocturia-related quality of life (N-QOL) [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656239
|Study Director:||Hilary McElwaine-Johnn, BSc, ASM, MBBS, MRCP, MFPM||Vantia Ltd|