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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00232076
Other study ID # COLO400D1303
Secondary ID
Status Completed
Phase Phase 3
First received October 3, 2005
Last updated November 1, 2011
Start date May 2004

Study information

Verified date November 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date March 2005
Accepts healthy volunteers
Gender Both
Age group 20 Years to 64 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
ciclosporin


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03052348 - Efficacy of Combining Topical Antibiotic/Steroid/Moisturizer Therapy Compared to Active Comparator in Atopic Dermatitis. N/A
Completed NCT00232063 - Long-term Study of Ciclosporin for Atopic Dermatitis Phase 3