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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00689832 |
Children with atopic eczema and a poor response to topical corticosteroid applied either Protopic or Fluticasone ointment twice a day for 3 weeks. They could continue during 3 more weeks once a day if needed.
Condition | Intervention | Phase |
---|---|---|
Dermatitis, Atopic |
Drug: Tacrolimus 0.03% Drug: Fluticasone 0.005% |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparative, Multicentre, Randomised, Double-Blind Study to Assess the Efficacy of Tacrolimus 0.03% Ointment Versus Fluticasone 0.005% Ointment in Children Aged 2 Years or Over Suffering From Moderate to Severe Atopic Dermatitis. |
Enrollment: | 487 |
Study Start Date: | February 2004 |
Study Completion Date: | August 2005 |
Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: Tacrolimus 0.03%
ointment
|
B: Active Comparator |
Drug: Fluticasone 0.005%
ointment
|
Treatments were to be applied twice daily until clearance, for a maximum of 3 weeks and then, in case of uncleared residual lesions, once daily for up to 3 further weeks. In the event of a flare-up the treatment was to be resumed twice a day until the end of the study.
Statistical methods: An interim analysis was performed on 30% of the planned total sample size, i.e. 140 included patients who had completed the study, to reassess the assumptions made during the planning phase.
Ages Eligible for Study: | 2 Years to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Astellas Pharma Europe BV ( Disclosure Office Europe ) |
Study ID Numbers: | FG-506-06-FR-05, EUDRACT #:2004-002478-47 |
Study First Received: | June 2, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00689832 |
Health Authority: | France: Afssaps - French Health Products Safety Agency; Belgium: Federal Agency for Medicinal Products and Health Products; Finland: National Agency for Medicines; Morocco: Ministry of Public Health; Tunisia: Office of Pharmacies and Medicines |
Dermatitis, Atopic Dermatologic Agents Topical Drug Administration Tacrolimus |
Calcineurin Corticosteroid Fluticasone propionate Child |
Hypersensitivity Dermatitis, Atopic Genetic Diseases, Inborn Skin Diseases Hypersensitivity, Immediate Fluticasone |
Skin Diseases, Eczematous Tacrolimus Eczema Skin Diseases, Genetic Dermatitis |
Anti-Inflammatory Agents Respiratory System Agents Immunologic Factors Immune System Diseases Physiological Effects of Drugs Anti-Asthmatic Agents Anti-Allergic Agents |
Immunosuppressive Agents Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents Dermatologic Agents |