NCT00232076

CompletedPhase 3

Verification Study of Ciclosporin for Atopic Dermatitis

Novartis Pharmaceuticals Source

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Other study identifiers

Sponsor study identifier

COLO400D1303

Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

0 countries

Sites

N/A

Timeline

Study Start

May 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2005

Actual (reported)

Study Completion

Not reported

Date not reported

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): Not reported
Study completion date: Not reported
Date not reported
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
May 2004
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
March 2005
Actual (reported)
First Submitted
October 3, 2005
Actual (reported)
First Posted
October 4, 2005
Actual (reported)

Last Updated: November 2, 2011
Status Verified: November 2011
Last Update Submitted: 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 \[according to the "Guidelines for Treatment of Atopic Dermatitis 2002, the severity of atopic dermatitis will be classified as severest when an eruption associated with severe inflammation (a lesion associated with erythema, papule, erosion, infiltration, lichenification, etc.) is noted on at least 30% of body surface on the day of subject enrollment\].

Sponsors & Collaborators

Novartis Pharmaceuticals
Industrylead

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)

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 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2005

Actual (reported)

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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.

Cyclosporins

Peptides, Cyclic

Macrocyclic Compounds

Polycyclic Compounds

Peptides

Amino Acids, Peptides, and Proteins

Last Updated

November 2, 2011

Record last verified: 2011-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00232076
Data provider: ClinicalTrials.gov
Source updated: 2011-11-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:08 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Conditions

Keywords

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record