search
Back to results

Long-term Study of Ciclosporin for Atopic Dermatitis

Primary Purpose

Severe Atopic Dermatitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ciclosporin
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Atopic Dermatitis focused on measuring Atopic Dermatitis, Ciclosporin,

Eligibility Criteria

20 Years - 64 Years (Adult)All Sexes

Inclusion Criteria: - 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]. Exclusion Criteria: 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.) Patients with hypertension, active infectional disease, gout etc. Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 3, 2005
    Last Updated
    November 1, 2011
    Sponsor
    Novartis Pharmaceuticals
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00232063
    Brief Title
    Long-term Study of Ciclosporin for Atopic Dermatitis
    Official Title
    Long-term Study of Ciclosporin for Atopic Dermatitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2004 (undefined)
    Primary Completion Date
    November 2005 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    In patients with severe adult atopic dermatitis, the safety and efficacy of OL27-400MEPC will be assessed by repeating oral administration at a dose of 3 mg/kg/day (2-5 mg/kg/day) in 2 divided doses daily for 8-12 weeks and recovery until 52 weeks after starting treatment

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Severe Atopic Dermatitis
    Keywords
    Atopic Dermatitis, Ciclosporin,

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    ciclosporin

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    64 Years
    Eligibility Criteria
    Inclusion Criteria: - 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]. Exclusion Criteria: 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.) Patients with hypertension, active infectional disease, gout etc. Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals Japan
    Organizational Affiliation
    Novartis Pharmaceuticals Japan
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Long-term Study of Ciclosporin for Atopic Dermatitis

    We'll reach out to this number within 24 hrs