Dose Response Study of VA106483 in Males With Nocturia and Benign Prostatic Hypertrophy (BPH)
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Purpose
The purpose of this study is to establish the dose response relationship of VA106483 and nocturnal urine volumes in a population of elderly male subjects with Benign Prostatic Hypertrophy (BPH) who are likely to present with nocturia.
| Condition | Intervention | Phase |
|---|---|---|
|
Nocturia Benign Prostatic Hypertrophy (BPH) |
Drug: VA106483 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomised, Double-blind, Placebo-controlled, Five-way Cross-over Dose Response Study to Determine the Effect of VA106483 on Nocturnal Urine Volume in Elderly Male Subjects With Nocturia and Benign Prostatic Hypertrophy (BPH) |
- Change in the mean nocturnal urine volumes [ Time Frame: 20 days ] [ Designated as safety issue: No ]
- Change in the mean nocturnal void frequency [ Time Frame: 20 days ] [ Designated as safety issue: No ]
- Change in mean time to first void [ Time Frame: 20 days ] [ Designated as safety issue: No ]
- Change in frequency of daytime voids [ Time Frame: 20 days ] [ Designated as safety issue: No ]
- Change in mean volume of daytime voids [ Time Frame: 20 days ] [ Designated as safety issue: No ]
- Change in mean nocturnal urine osmolality [ Time Frame: 20 days ] [ Designated as safety issue: No ]
- Change in mean daytime urine osmolality [ Time Frame: 20 days ] [ Designated as safety issue: No ]
- Change in mean voided volumes [ Time Frame: 20 days ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | March 2011 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: VA106483 0.5 mg |
Drug: VA106483
Once daily oral dose of placebo for 2 nights Once daily oral dose of 0.5 mg VA106483 for 2 nights Once daily oral dose of 1 mg VA106483 for 2 nights Once daily oral dose of 2 mg VA106483 for 2 nights Once daily oral dose of 4 mg VA106483 for 2 nights Placebo: as above |
| Experimental: VA106483 1 mg |
Drug: VA106483
Once daily oral dose of placebo for 2 nights Once daily oral dose of 0.5 mg VA106483 for 2 nights Once daily oral dose of 1 mg VA106483 for 2 nights Once daily oral dose of 2 mg VA106483 for 2 nights Once daily oral dose of 4 mg VA106483 for 2 nights Placebo: as above |
| Experimental: VA106483 2 mg |
Drug: VA106483
Once daily oral dose of placebo for 2 nights Once daily oral dose of 0.5 mg VA106483 for 2 nights Once daily oral dose of 1 mg VA106483 for 2 nights Once daily oral dose of 2 mg VA106483 for 2 nights Once daily oral dose of 4 mg VA106483 for 2 nights Placebo: as above |
| Experimental: VA106483 4 mg |
Drug: VA106483
Once daily oral dose of placebo for 2 nights Once daily oral dose of 0.5 mg VA106483 for 2 nights Once daily oral dose of 1 mg VA106483 for 2 nights Once daily oral dose of 2 mg VA106483 for 2 nights Once daily oral dose of 4 mg VA106483 for 2 nights Placebo: as above |
| Placebo Comparator: Sugar pill |
Drug: VA106483
Once daily oral dose of placebo for 2 nights Once daily oral dose of 0.5 mg VA106483 for 2 nights Once daily oral dose of 1 mg VA106483 for 2 nights Once daily oral dose of 2 mg VA106483 for 2 nights Once daily oral dose of 4 mg VA106483 for 2 nights Placebo: as above |
Detailed Description:
VA106483 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 waking to void at least once per night between periods of sleep, 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 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).
Correlation between nocturnal urine volume and nocturnal void frequency has been demonstrated in previous studies of V2-receptor agonists.
The purpose of this study is to determine the dose response relationship of VA106483 and nocturnal urine volumes.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males aged 65 years old and above with history of nocturia and benign prostatic hypertrophy (BPH)
Exclusion Criteria:
- Administration of any Investigational Medicinal Product (IMP) within 10 weeks before entry to the study
- Any clinically significant concomitant medical disease, condition or abnormal laboratory test result
- Other protocol defined eligibility criteria may apply
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dr Hilary McElwaine-Johnn / Chief Medical Officer, Vantia Ltd, 1 Venture Road, Southampton Science Park, Southampton, SO16 7NP, UK |
| ClinicalTrials.gov Identifier: | NCT01330927 History of Changes |
| Other Study ID Numbers: | 483-008 |
| Study First Received: | March 30, 2011 |
| Last Updated: | August 1, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Vantia Ltd:
|
VA106483 Nocturia Benign Prostatic Hypertrophy BPH |
Elderly Males Nocturnal voids Anti-diuretic |
Additional relevant MeSH terms:
|
Prostatic Hyperplasia Hypertrophy Nocturia Prostatic Diseases |
Genital Diseases, Male Pathological Conditions, Anatomical Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013