Severe Atopic DermatitisPhase 3NCT00232063
Long-term Study of Ciclosporin for Atopic Dermatitis
A Phase 3 study testing ciclosporin in people with Severe Atopic Dermatitis, run by Novartis Pharmaceuticals.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Severe Atopic Dermatitis
- What is being tested?
- ciclosporin
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- May 2004to Nov 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- Adult
Who may be able to join
- - 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].
Who cannot join
- 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.
About this study
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
- Conditions
- Severe Atopic Dermatitis
- Being tested
- ciclosporin
- Keywords
- Atopic Dermatitis, Ciclosporin,
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciclosporinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startMay 2004
- Primary completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals Japan, Study chair, Novartis Pharmaceuticals Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232063
- Sponsor's protocol ID
- COLO400D1304
- Status last verified
- Nov 2011
- First submitted
- 3 Oct 2005
- Last updated
- 2 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Study of Ciclosporin for Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00232063
- Acronym / sponsor ID
- COLO400D1304
- Conditions
- Severe Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Ciclosporin,
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Nov 2005 (actual)
- First posted
- 4 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (2 listed)
- - 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].
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ciclosporin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals Japan study chair
Novartis Pharmaceuticals Japan
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ciclosporin in people with Severe Atopic Dermatitis, run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2011.