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.
Sponsor:
Ferring Pharmaceuticals
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00209261
First received: September 13, 2005
Last updated: May 18, 2011
Last verified: May 2011
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Nocturnal Enuresis |
Drug: MINIRIN Oral Lyophilisate Drug: Minirin tablet |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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) |
Resource links provided by NLM:
Further study details as provided by Ferring Pharmaceuticals:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 221 |
| Study Start Date: | December 2004 |
| Study Completion Date: | September 2005 |
| Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 | Drug: MINIRIN Oral Lyophilisate |
| Active Comparator: 2 | Drug: Minirin tablet |
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
Eligibility| Ages Eligible for Study: | 5 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209261
Locations
| France | |
| Service de Chirurrgie Viscerale Pediatrique Hospital Necker-Enfants Malades | |
| Paris, France | |
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
| Study Director: | Clinical Development Support | Ferring Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Clinical Development Support, Ferring Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00209261 History of Changes |
| Other Study ID Numbers: | FE992026 CS022 |
| Study First Received: | September 13, 2005 |
| Last Updated: | May 18, 2011 |
| Health Authority: | Sweden: Medical Products Agency |
Additional relevant MeSH terms:
|
Enuresis Nocturnal Enuresis Urination Disorders Urologic Diseases Behavioral Symptoms Elimination Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Deamino Arginine Vasopressin |
Antidiuretic Agents Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 17, 2013