Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
5 participants
INTERVENTIONAL
2013-04-30
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental A
Desmopressin
Experimental B
Desmopressin
Placebo
Placebo (not active)
Interventions
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Desmopressin
Placebo (not active)
Eligibility Criteria
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Inclusion Criteria
* Habitual sleep of 6-9.5 hours per night
* Experiencing symptoms of Nocturia greater than 6 months
Exclusion Criteria
* History of sleep apnoea and PLMS (Periodic Limb Movements of Sleep)
* Other sleep disorders
* Signs or symptoms of: Bladder outlet obstruction, severe lower urinary tract symptoms (LUTS), interstitial cystitis, moderate to severe overactive bladder (OAB), moderate to severe as judged by the investigator stress urinary incontinence
* Urological malignancies
* Neurogenic detrusor over activity (e.g. Parkinson, spinal cord damage, etc.)
* Central or nephrogenic diabetes insipidus
* Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding 40ml/Kg/24hrs)
* Syndrome of inappropriate antidiuretic hormone (SIADH)
* Cardiac failure evidence based on physical examination, cardiac medical history and electrocardiogram (ECG) output
* Uncontrolled hypertension
* Uncontrolled diabetes mellitus
* Hyponatraemia with sodium \<135 mmol/L
* Renal insufficiency
* Known or suspected clinically significant hepatic and/or biliary diseases
25 Years
65 Years
ALL
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Surrey Clinical Research Centre
Surrey, , United Kingdom
Countries
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Other Identifiers
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2012-004388-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
000088
Identifier Type: -
Identifier Source: org_study_id
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