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:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00209261
First received: September 13, 2005
Last updated: May 18, 2011
Last verified: May 2011
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Ferring Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Urination Disorders
Urologic Diseases
Deamino Arginine Vasopressin
Antidiuretic Agents
Cardiovascular Agents
Coagulants
Hematologic Agents
Hemostatics
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014