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Sponsored by: |
Ferring Pharmaceuticals |
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Information provided by: | Ferring Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00209261 |
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) |
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 |
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
Ages Eligible for Study: | 5 Years to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
France | |
Service de Chirurrgie Viscerale Pediatrique Hospital Necker-Enfants Malades | |
Paris, France |
Study Director: | Clinical Development Support | Ferring Pharmaceuticals |
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 |
Arginine Vasopressin Urologic Diseases Nocturnal Enuresis Mental Disorders Urination Disorders Enuresis |
Deamino Arginine Vasopressin Mental Disorders Diagnosed in Childhood Vasopressins Cardiovascular Agents Hemostatics Behavioral Symptoms |
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 |