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To evaluate the preference of subjects for MinirinĀ® oral lyophilisate treatment compared with MinirinĀ® 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 MinirinĀ® oral lyophilisate treatment compared with MinirinĀ® 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MINIRIN Oral Lyophilisate | Drug |
| ||
| Minirin tablet |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks (melt) and 6 weeks (tablet). Total 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy will be measured as the difference in the incidence of bedwetting episodes during each 3-week treatment period, compared between formulations. | 3 weeks | |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Chirurrgie Viscerale Pediatrique Hospital Necker-Enfants Malades | Paris | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40728007 | Derived | Hahn D, Stewart F, Raman G. Desmopressin for nocturnal enuresis in children. Cochrane Database Syst Rev. 2025 Jul 29;7(7):CD002112. doi: 10.1002/14651858.CD002112.pub2. | |
| 32364251 | Derived | Caldwell PH, Codarini M, Stewart F, Hahn D, Sureshkumar P. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2020 May 4;5(5):CD002911. doi: 10.1002/14651858.CD002911.pub3. |
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|
| 3 weeks |
| Subjects will be asked to complete a QoL questionnaire at visit 2 and visit 3. | 3 weeks |
| Safety comparison between the 2 formulations. | 6 weeks |
| Comparison of compliance between the 2 formulations. | 6 weeks |
| The subjects will be asked a question regarding which treatment (MinirinĀ® oral lyophilisate or MinirinĀ® tablet) they preferred at the end of 6 weeks treatment. | 6 weeks (melt) and 6 weeks (tablet). Total 12 weeks. |
| 23677249 | Derived | Juul KV, Van Herzeele C, De Bruyne P, Goble S, Walle JV, Norgaard JP. Desmopressin melt improves response and compliance compared with tablet in treatment of primary monosymptomatic nocturnal enuresis. Eur J Pediatr. 2013 Sep;172(9):1235-42. doi: 10.1007/s00431-013-1992-9. Epub 2013 May 16. |
| ID | Term |
|---|---|
| D003894 | Deamino Arginine Vasopressin |
| ID | Term |
|---|---|
| D001127 | Arginine Vasopressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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