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| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | February 19, 2009 | ||||
| Start Date ICMJE | December 2004 | ||||
| Primary Completion Date | August 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00209261 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | 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) | ||||
| Official Title ICMJE | 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) | ||||
| Brief Summary | 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 |
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| Detailed Description | 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 |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Crossover Assignment | ||||
| Condition ICMJE | Primary Nocturnal Enuresis | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 221 | ||||
| Completion Date | September 2005 | ||||
| Primary Completion Date | August 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 5 Years to 15 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00209261 | ||||
| Responsible Party | Hjort, Director, Ferring Pharmaceuticals | ||||
| Study ID Numbers ICMJE | FE992026 CS022 | ||||
| Study Sponsor ICMJE | Ferring Pharmaceuticals | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Ferring Pharmaceuticals | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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