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) - Full Text View

Sponsor:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00209261

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment
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:

MedlinePlus related topics: Toilet Training

U.S. FDA Resources

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
Estimated Study Completion Date:	September 2005
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: MINIRIN Oral Lyophilisate
2: Active Comparator	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:	Ferring Pharmaceuticals ( Hjort, Director )
Study ID Numbers:	FE992026 CS022
Study First Received:	September 13, 2005
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00209261 History of Changes
Health Authority:	Sweden: Medical Products Agency

Additional relevant MeSH terms:

Coagulants
Enuresis
Urination Disorders
Elimination Disorders
Hematologic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Hemostatics
Pharmacologic Actions

Behavioral Symptoms
Nocturnal Enuresis
Urologic Diseases
Mental Disorders
Natriuretic Agents
Therapeutic Uses
Deamino Arginine Vasopressin
Mental Disorders Diagnosed in Childhood
Antidiuretic Agents

ClinicalTrials.gov processed this record on November 05, 2009