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| Sponsored by: |
Astellas Pharma Inc |
| Information provided by: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00535691 |
Purpose
The purpose of this study is to estimate the systemic exposure to tacrolimus in infants with atopic dermatitis after repeated application of tacrolimus ointment. Efficacy of tacrolimus ointment, evaluated by examination of treated areas, will also be measured.
| Condition | Intervention | Phase |
|
Dermatitis, Atopic |
Drug: Tacrolimus Ointment 0.03% |
Phase II |
| ChemIDplus related topics: | Tacrolimus Tacrolimus anhydrous |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomised, Multi-Centre, Double-Blind, Pharmacokinetic Study of Tacrolimus Ointment (0.03%) in Paediatric Patients (Aged 3 Months to 24 Months) With Atopic Dermatitis Following First and Repeated Once Daily or Twice Daily Application of the Tacrolimus Ointment |
| Enrollment: | 53 |
| Study Start Date: | April 2003 |
| Study Completion Date: | December 2004 |
| Arms | Assigned Interventions |
|
1: Active Comparator
Tacrolimus ointment 0.03% once daily, placebo once daily
|
Drug: Tacrolimus Ointment 0.03%
Once daily, 14 days treatment.
|
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2: Active Comparator
Tacrolimus ointment 0.03% twice daily
|
Drug: Tacrolimus Ointment 0.03%
Twice daily, 14 days treatment.
|
This is a multi-centre, double-blind, randomised phase II pharmacokinetic study in infants (3 - 24 months old) suffering from atopic dermatitis and requiring treatment with mid potency topical steroids. Patients will primarily be stratified into three groups according to percentage body surface area to be treated and subsequently randomised into treatment groups of once a day (UID) or twice a day (BID) tacrolimus ointment (0.03%) regimens. There will ultimately be a total of six groups. The study will be conducted on an out-patient basis, with each patient's parent/legal representative administering the ointment at home. However all medications on days 1 and 14 will be applied in the clinic by the Investigator or his/her designee, as will the morning application on day 4. The ointment application period will be two weeks with a follow-up period of four days. All patients enrolled into the study, who applied at least one dose of study medication and who benefited from treatment will be given the opportunity to enter a long-term study to follow (FG-506-06-33).
The patient will be entered into one of the following three groups:
Stratification Group I Application area of 5 - 20% Stratification Group II Application area of > 20 - 40% Stratification Group III Application area of > 40%
Within these groups the patients will be randomised to either UID or BID.
Eligibility
| Ages Eligible for Study: | 3 Months to 24 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada | |||||
| Vancouver, Canada | |||||
| Waterloo, Canada | |||||
| Halifax, Canada | |||||
| Finland | |||||
| Helsinki, Finland | |||||
| Ireland | |||||
| Dublin, Ireland | |||||
| Drogheda, Ireland | |||||
| Latvia | |||||
| Riga, Latvia | |||||
| United Kingdom | |||||
| London, United Kingdom | |||||
| Astellas Pharma Inc |
| Study Chair: | Central Contact | Astellas Pharma GmbH |
More Information
| Study ID Numbers: | FG-506-06-32 |
| First Received: | September 21, 2007 |
| Last Updated: | September 24, 2007 |
| ClinicalTrials.gov Identifier: | NCT00535691 |
| Health Authority: | Finland: National Agency for Medicines; Latvia: State Agency of Medicines; Canada: Health Canada; Ireland: Irish Medicines Board; United Kingdom: Department of Health |
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