Daytime Impact Sleep Study

NCT ID: NCT01779466

Last Updated: 2015-04-27

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-06-30

Brief Summary

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This trial will investigate the relationship of sleep, daytime performance and nocturia in patients treated with Desmopressin or placebo. Male and Female patients will be administered Desmopressin or Placebo every day for 3 months.

Detailed Description

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Conditions

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Nocturia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental A

Group Type EXPERIMENTAL

Desmopressin

Intervention Type DRUG

Experimental B

Group Type EXPERIMENTAL

Desmopressin

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo (not active)

Intervention Type DRUG

Interventions

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Desmopressin

Intervention Type DRUG

Placebo (not active)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* At least 2 night time voids per night
* Habitual sleep of 6-9.5 hours per night
* Experiencing symptoms of Nocturia greater than 6 months

Exclusion Criteria

* Greater than 10 night time voids
* 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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United Kingdom

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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