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A 6-Week Open Label Cross-Over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate in Children and Adolescents With Primary Nocturnal Enuresis (PNE) (PALAT)
This study has been completed.
Study NCT00209261   Information provided by Ferring Pharmaceuticals
First Received: September 13, 2005   Last Updated: February 19, 2009   History of Changes

September 13, 2005
February 19, 2009
December 2004
August 2005   (final data collection date for primary outcome measure)
The primary endpoint will be the difference in the proportion of subjects who preferred each formulation at the end of the 6-week treatment period. [ Time Frame: 6 weeks (melt) and 6 weeks (tablet). Total 12 weeks. ] [ Designated as safety issue: No ]
  • The primary endpoint will be the difference in the proportion of subjects who preferred each formulation at the end of the 6-week treatment period.
  • The subjects will be asked a question regarding which treatment (Minirin® oral lyophilisate or Minirin® tablet) they preferred at the end of 6 weeks treatment.
Complete list of historical versions of study NCT00209261 on ClinicalTrials.gov Archive Site
  • Efficacy will be measured as the difference in the incidence of bedwetting episodes during each 3-week treatment period, compared between formulations. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • The subjects will be asked to rate the ease of use of each formulation using a 100 mm Visual Analogue Scale (VAS), with 0 = I find it very easy to use this medicine and 100 = I find it very difficult to use this medicine. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Subjects will be asked to complete a QoL questionnaire at visit 2 and visit 3. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Safety comparison between the 2 formulations. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Comparison of compliance between the 2 formulations. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • The subjects will be asked a question regarding which treatment (Minirin® oral lyophilisate or Minirin® tablet) they preferred at the end of 6 weeks treatment. [ Time Frame: 6 weeks (melt) and 6 weeks (tablet). Total 12 weeks. ] [ Designated as safety issue: No ]
  • Efficacy will be measured as the difference in the incidence of bedwetting episodes during each 3-week treatment period, compared between formulations.
  • The subjects will be asked to rate the ease of use of each formulation using a 100 mm Visual Analogue Scale (VAS), with 0 = I find it very easy to use this medicine and 100 = I find it very difficult to use this medicine.
  • Subjects will be asked to complete a QoL questionnaire at visit 2 and visit 3.
  • Safety comparison between the 2 formulations.
  • Comparison of compliance between the 2 formulations.
 
A 6-Week Open Label Cross-Over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate in Children and Adolescents With Primary Nocturnal Enuresis (PNE)
A 6-Week Open Label Cross-Over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate (120 μg and 240 μg) and 2 Different Daily Doses of Minirin® Tablet (0.2 mg and 2 x 0.2 mg) in Children and Adolescents With Primary Nocturnal Enuresis (PNE)

To evaluate the preference of subjects for Minirin® oral lyophilisate treatment compared with Minirin® tablet treatment after 6 weeks.

To compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data.

To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2 formulations

To evaluate the preference of subjects for Minirin® oral lyophilisate treatment compared with Minirin® tablet treatment after 6 weeks.

To compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data.

To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2 formulations

Phase IV
Interventional
Treatment, Randomized, Open Label, Active Control, Crossover Assignment
Primary Nocturnal Enuresis
  • Drug: MINIRIN Oral Lyophilisate
  • Drug: Minirin tablet
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
221
September 2005
August 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children suffering from primary nocturnal enuresis with no organic pathology.
  • Children of either sex, not below 5 and not above 15 years of age (not below 6 years in The Netherlands and France).
  • Children with a minimum of 6 wet nights in 2 weeks.

Exclusion Criteria:

  • Children who have previously been treated with desmopressin or other medications for nocturnal enuresis or enuresis alarms.
  • Children receiving substances that are known or suspected to potentiate antidiuretic hormone, e.g. SSRI, tricyclic antidepressant drugs, chlorpromazine and carbamazepine.
  • Diagnosed renal diabetes insipidus or central diabetes insipidus with an AVP (arginine vasopressin) deficiency.
  • Proven urinary tract infection within the past month or a documented positive urine culture at the start of the study
Both
5 Years to 15 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00209261
Hjort, Director, Ferring Pharmaceuticals
FE992026 CS022
Ferring Pharmaceuticals
 
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
February 2009

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