NCT00232076

Brief Summary

To assess the efficacy and safety of oral OL27-400MEPC 3 mg/kg/day (2-5 mg/kg/day) in 2 divided doses daily for 8 weeks to patients with severe adult atopic dermatitis. THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
completed

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
Last Updated

November 2, 2011

Status Verified

November 1, 2011

Enrollment Period

10 months

First QC Date

October 3, 2005

Last Update Submit

November 1, 2011

Conditions

Severe Atopic Dermatitis

Keywords

Atopic Dermatitis, Ciclosporin,

Interventions

ciclosporinDRUG

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • Appropriate the definition/diagnosis criteria of atopic dermatitis of the Japanese Dermatological Association
  • Patients with severest atopic dermatitis \[according to the "Guidelines for Treatment of Atopic Dermatitis 2002, the severity of atopic dermatitis will be classified as severest when an eruption associated with severe inflammation (a lesion associated with erythema, papule, erosion, infiltration, lichenification, etc.) is noted on at least 30% of body surface on the day of subject enrollment\].

You may not qualify if:

  • \- Patients who received oral preparations, injections, inhaled preparations and suppositories of steroids or immunosuppressants other than tacrolimus hydrate ointments within 14 days of subject enrollment
  • Patients who might receive the oral/injection drugs which are known to enhance nephrotoxicity, increase serum potassium levels, HMG-CoA reductase inhibitors or theophylline during the treatment period.
  • Patients who received or are receiving an ultraviolet therapy (PUVA therapy, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Novartis Pharmaceuticals Japan

    Novartis Pharmaceuticals Japan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2005

First Posted

October 4, 2005

Study Start

May 1, 2004

Primary Completion

March 1, 2005

Last Updated

November 2, 2011

Record last verified: 2011-11