Study With Two Different Doses of Desmopressin Melt Tablet With Nocturnal Enuresis
Summary
This is multi-center, randomized, placebo-controlled, parallel-group, double-blind, dose-escalating clinical trial designed to assess the efficacy and safety of desmopressin lyophilisate for the treatment of nocturnal enuresis "with decreased nighttime urinary osmolality."
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Nocturnal Enuresis
Intervention
Desmopressin, Placebo
Location
Shinko-kakogawa hospital
Kakogawa
Hyogo
Japan
Status
Recruiting
Source
Ferring Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01078753
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-23T21:09:57-0400
Clinical Trials
The aim of this study is to investigate the importance of clinical characterization of children with monosymptomatic nocturnal enuresis (MNE) in order to improve treatment efficacy. ...
Patients suffering from nocturnal enuresis (starting from the age of 5 till adulthood) are all treated with the same dose of desmopressin, i.e. 120mcg once daily. In treatment resistant en...
Monosymptomatic nocturnal enuresis (MEN) is a common problem in children, affecting 7-10% of all 7 year olds. MEN is often leading to psychosocial problems because of its burden and stigma...
Desmopressin as a Therapy for Bedwetting in Children With Sickle Cell Disease
This study assesses if using the medication desmopressin will decrease nightime bedwetting in children with sickle cell disease. Half of the children will receive placebo and half of the c...
Nocturia is defined as waking one or more times to void during the period between going to bed with the intention of sleeping and waking with the intention of arising.The pathophysiology o...
PubMed Articles
To investigate the beneficial effect of adenotonsillectomy (AT) on nocturnal enuresis (NE) in children with adenotonsillar hypertrophy and evaluate the Modified Pediatric Epworth Scale (MPES).
To investigate whether infant temperament and childhood internalizing, externalizing, and inattention symptoms increase the likelihood of daytime urinary incontinence or nocturnal enuresis at 10 years...
Primary nocturnal enuresis (PNE) is a challenging condition for physicians, patients and families. Although the etiology remains unclear, sleep-disordered breathing (SDB) and sleep apnea have been sug...
Placebo analgesia persists during sleep: An experimental study.
Although placebo analgesia is a well-recognized phenomenon with important clinical implications, the possibility that placebo effects occur during sleep has received little attention. This experimenta...
Primary and Secondary Enuresis: Pathophysiology, Diagnosis, and Treatment.
Enuresis is a common and possibly underestimated condition. While 5-10% of school-aged children suffer from the condition, a lack of background knowledge may impede timely child-adapted and successful...
Medical and Biotech [MESH] Definitions
Enuresis
Involuntary discharge of URINE after expected age of completed development of urinary control. This can happen during the daytime (DIURNAL ENURESIS) while one is awake or during sleep (NOCTURNAL ENURESIS). Enuresis can be in children or in adults (as persistent primary enuresis and secondary adult-onset enuresis).
Nocturnal Enuresis
Involuntary discharge of URINE during sleep at night after expected age of completed development of urinary control.
Myoclonus
Involuntary shock-like contractions, irregular in rhythm and amplitude, followed by relaxation, of a muscle or a group of muscles. This condition may be a feature of some CENTRAL NERVOUS SYSTEM DISEASES; (e.g., EPILEPSY, MYOCLONIC). Nocturnal myoclonus is the principal feature of the NOCTURNAL MYOCLONUS SYNDROME. (From Adams et al., Principles of Neurology, 6th ed, pp102-3).
Diurnal Enuresis
Involuntary discharge of URINE during the daytime while one is awake.
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
