Long-Term Safety of Protopic in Atopic Eczema - Full Text View

Purpose

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%

Condition	Intervention	Phase
Dermatitis, Atopic Eczema, Atopic	Drug: Tacrolimus ointment 0.1%	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Long-Term, Open Label, Noncomparative Study to Evaluate the Safety of 0.1% Tacrolimus (FK506) Ointment for Treatment of Atopic Dermatitis

Resource links provided by NLM:

MedlinePlus related topics: Eczema

Drug Information available for: Tacrolimus

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Incidence of adverse events [ Time Frame: 4 Years ]

Secondary Outcome Measures:

Haematology and biochemistry parameters and vital signs [ Time Frame: 4 Years ]

Enrollment:	789
Study Start Date:	June 1998
Study Completion Date:	June 2005

Arms	Assigned Interventions
Experimental: Tacrolimus Ointment 0.1%	Drug: Tacrolimus ointment 0.1% Topical Other Name: Protopic

Detailed Description:

A long-term, multi-centre, open label, non-comparative phase III study in patients with atopic dermatitis. All centres in Europe which have participated or are still participating in the FG-506-06-12, FG-506-06-18 or FG-506-06-19, FG-506-06-22 or FG-506-06-23 studies will be offered a participation in the protocol. Only patients enrolled by those centres for the above mentioned studies, who have received at least one dose of study medication can be enrolled. Tacrolimus ointment 0.1% will be administered until clearance of the skin occurs. Treatment is restarted after signs and symptoms reoccur. Safety will be assessed from adverse events reported by the patient/parent/guardian or observed by the investigator at the site of application and elsewhere. The safety evaluation will include monitoring of routine hematology and serum chemistry parameters at Baseline/Day 1, Week 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42 and/or at the end of the study (End-of-Study Visit).

Eligibility

Ages Eligible for Study:	2 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560378

Show 42 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Central Contact

Astellas Pharma GmbH

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00560378 History of Changes
Other Study ID Numbers:	FG-506-06-21
Study First Received:	November 16, 2007
Last Updated:	December 3, 2008
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Ireland: Irish Medicines Board Latvia: State Agency of Medicines Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Spain: Spanish Agency of Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:

Tacrolimus
Administration, topical
Drug safety
Adults
Children

Additional relevant MeSH terms:

Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate

Hypersensitivity
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013