Primary Nocturnal Enuresis Clinical Trial
— PALATOfficial title:
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)
| Verified date | May 2011 |
| Source | Ferring Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Medical Products Agency |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 221 |
| Est. completion date | September 2005 |
| Est. primary completion date | August 2005 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 5 Years to 15 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Service de Chirurrgie Viscerale Pediatrique Hospital Necker-Enfants Malades | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Ferring Pharmaceuticals |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | No | |
| Secondary | Efficacy will be measured as the difference in the incidence of bedwetting episodes during each 3-week treatment period, compared between formulations. | 3 weeks | No | |
| Secondary | 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. | 3 weeks | No | |
| Secondary | Subjects will be asked to complete a QoL questionnaire at visit 2 and visit 3. | 3 weeks | No | |
| Secondary | Safety comparison between the 2 formulations. | 6 weeks | Yes | |
| Secondary | Comparison of compliance between the 2 formulations. | 6 weeks | Yes | |
| Secondary | 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. | 6 weeks (melt) and 6 weeks (tablet). Total 12 weeks. | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00230594 -
Desmopressin Response in the Young
|
Phase 3 |