Long-term Safety of Protopic in Atopic Eczema

NCT00560378 | Completed Phase 3 DMC

• 1 other identifier: FG-506-06-21
• Study Type: interventional
• Target: 789
• Locations: 12 countries
• Sites: 41

Brief Summary

Patients who have participated in previous studies with Tacrolimus ointment for atopic eczema are entitled to enter this four-year follow study to investigate the safety of treatment with Tacrolimus ointment 0.1%

Conditions

Dermatitis, Atopic; Eczema, Atopic

Keywords

Tacrolimus; Administration, topical; Drug safety; Adults; Children

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  4 Years

Secondary Outcomes (1)

• Haematology and biochemistry parameters and vital signs

  4 Years

Study Arms (1)

Tacrolimus Ointment 0.1%

EXPERIMENTAL

Drug: Tacrolimus ointment 0.1%

Interventions

Tacrolimus ointment 0.1% DRUG

Topical

Also known as: Protopic

Tacrolimus Ointment 0.1%

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Every patient who has participated in the FG-506-06-12, FG-506-06-18, FG-506-06-19, FG-506-06-22 or FG-506-06-23 study, and has received at least one dose of study medication
• Patient is likely to benefit from further treatment with Tacrolimus (FK506) ointment in the opinion of the investigator
• Patient has atopic dermatitis with Body surface involvement between 5% and 60% for patients with the age of 2 years to 15 years (not having reached their 16th birthday) and between 5% and 100% for patients with 16 years of age or older

You may not qualify if:

• Patient has an infection requiring treatment
• Patient is known to be HIV positive
• Patient has a systemic disease, including cancer or history of cancer or AIDS, which would contraindicate the use of Tacrolimus (FK506) ointment

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (41)

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Brussels, Belgium

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Aarhus, Denmark

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Helsinki, Finland

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Tampere, Finland

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Turku, Finland

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Bordeaux, France

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Brest, France

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Gaël, France

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Lyon, France

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Nantes, France

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Paris, France

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Pessac, France

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Quimper, France

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Saint-Etienne, France

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Tours, France

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Bonn, Germany

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Düsseldorf, Germany

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Erlangen, Germany

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Freiburg im Breisgau, Germany

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Hamburg, Germany

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Hanover, Germany

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München, Germany

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Münster, Germany

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Tübingen, Germany

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Szeged, Hungary

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Cork, Ireland

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Dublin, Ireland

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Riga, Latvia

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Amsterdam, Netherlands

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Warsaw, Poland

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Barcelona, Spain

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Madrid, Spain

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Seville, Spain

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Cardiff, United Kingdom

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Coventry, United Kingdom

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Lancaster, United Kingdom

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Leicester, United Kingdom

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Liverpool, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Southhampton, United Kingdom

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Related Publications (1)

• Reitamo S, Rustin M, Harper J, Kalimo K, Rubins A, Cambazard F, Brenninkmeijer EE, Smith C, Berth-Jones J, Ruzicka T, Sharpe G, Taieb A; 0.1% Tacrolimus Ointment Long-term Follow-up Study Group. A 4-year follow-up study of atopic dermatitis therapy with 0.1% tacrolimus ointment in children and adult patients. Br J Dermatol. 2008 Sep;159(4):942-51. doi: 10.1111/j.1365-2133.2008.08747.x. Epub 2008 Jul 15.

  PMID: 18637898 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Central Contact

  Astellas Pharma GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2007
• First Posted: November 19, 2007
• Study Start: June 1, 1998
• Study Completion: June 1, 2005
• Last Updated: September 18, 2014

Record last verified: 2014-09

Locations

NL (1); PL (1); ES (3); GB (8); FI (3); DE (9); FR (10); HU (1); BE (1); IE (2); DK (1); LA (1)