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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00560326 |
The objective of this study is to assess the safety and efficacy of 0.03% tacrolimus ointment as long-term treatment in paediatric patients with atopic dermatitis.
Condition | Intervention | Phase |
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Dermatitis, Atopic |
Drug: Tacrolimus Ointment 0.03% |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Long-Term, Non-Comparative Study to Evaluate the Safety and Efficacy of Tacrolimus Oint¬Ment in Paediatric Patients |
Enrollment: | 50 |
Study Start Date: | June 2003 |
Study Completion Date: | December 2006 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Tacrolimus Ointment 0.03%
Once or twice daily topical application
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This is a long-term, multi-centre, non-comparative phase II study. All centres participating in the FG-506-06-32 pharmacokinetics study will be offered the protocol as a follow-up. Only patients enrolled by those centres for the above mentioned study, who applied at least one dose of study medication and benefited from treatment with 0.03% tacrolimus ointment, can be enrolled.
During episodes of active disease, a thin coat of ointment is applied on each lesion. In the first three weeks, frequency of application is twice a day; after three weeks treatment is continued once a day. All atopic dermatitis lesions are treated until clearance (i.e. itch has gone). In case of a flare-up or worsening treatment twice daily treatment is re-started for three weeks and thereafter reduced to once daily.
Safety is assessed from adverse events reported by the patient and/or his parents or observed by the investigator at the site of application and elsewhere. The safety evaluation includes monitoring of routine haematology and serum chemistry parameters. Blood samples are analysed by local laboratories. Blood samples are taken to determine concentrations of tacrolimus. Height, weight and pulse of the patient are recorded at each visit.
Efficacy is assessed by physician's global evaluation of clinical response, patient's parent/guardian's assessment of global response, physician's assessment of individual signs and the affected area assessment.
Ages Eligible for Study: | 6 Months to 30 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada | |
Vancouver, Canada | |
Waterloo, Canada | |
Halifax, Canada | |
Finland | |
Helsinki, Finland | |
Ireland | |
Dublin, Ireland | |
Drogheda, Ireland | |
Latvia | |
Riga, Latvia | |
United Kingdom | |
London, United Kingdom |
Study Chair: | Central Contact | Astellas Pharma Europe BV |
Study ID Numbers: | FG-506-06-33 |
Study First Received: | November 16, 2007 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00560326 History of Changes |
Health Authority: | Finland: National Agency for Medicines; Latvia: State Agency of Medicines; Canada: Health Canada; Ireland: Irish Medicines Board; United Kingdom: Department of Health |
Paediatric patients Tacrolimus Dermatitis, Atopic |
Hypersensitivity Dermatitis, Atopic Immunologic Factors Genetic Diseases, Inborn Skin Diseases Hypersensitivity, Immediate |
Skin Diseases, Eczematous Tacrolimus Immunosuppressive Agents Skin Diseases, Genetic Dermatitis |
Dermatitis, Atopic Skin Diseases Immune System Diseases Immunologic Factors Physiological Effects of Drugs Tacrolimus Immunosuppressive Agents |
Pharmacologic Actions Hypersensitivity Genetic Diseases, Inborn Hypersensitivity, Immediate Skin Diseases, Eczematous Skin Diseases, Genetic Dermatitis |