Extension Study to Assess Safety and Efficacy of Pimecrolimus in Adult Patients With Atopic Dermatitis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00232011 |
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Recruitment Status
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Completed
First Posted
: October 4, 2005
Last Update Posted
: December 17, 2007
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Pimecrolimus, which is an ascomycin derivative, is an anti-inflammatory non-steroidal agent. In this study, the long-term safety and efficacy of pimecrolimus cream will be evaluated in Japanese adult patients with atopic dermatitis. This study is a 6-month extension study following core study.
THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atopic Dermatitis | Drug: Pimecrolimus Cream 1% | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 160 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Clinical Study Continued From the Confirmatory Study to Assess the Efficacy and Safety of ASM981 Cream in Adult Atopic Dermatitis Patients |
| Study Start Date : | May 2004 |
| Actual Study Completion Date : | May 2005 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1 |
Drug: Pimecrolimus Cream 1%
Pimecrolimus cream 1 %
Other Name: Elidel
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- Safety assessed by adverse events (AEs)
- Number of disease flares during 26 weeks of treatment
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| Ages Eligible for Study: | 16 Years to 65 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
Inclusion Criteria:
- Patients who had completed the core study and whose participation in this study was considered appropriate as judged by the investigator
- Patients who had given written informed consent to participation in this study
Exclusion Criteria:
- Patients who failed in treatment compliance in the core study
- Patients who had a major violation of the protocol in the core study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232011
| Japan | |
| This study is not being conducted in the United States | |
| Various Cities, Japan | |
| Study Chair: | Novartis Pharmaceuticals Japan | Novartis Pharmaceuticals Japan |
| Responsible Party: | External Affairs, Novartis |
| ClinicalTrials.gov Identifier: | NCT00232011 History of Changes |
| Other Study ID Numbers: |
CASM981C1304 |
| First Posted: | October 4, 2005 Key Record Dates |
| Last Update Posted: | December 17, 2007 |
| Last Verified: | December 2007 |
Keywords provided by Novartis:
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Atopic dermatitis, ASM981, pimecrolimus |
Additional relevant MeSH terms:
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Dermatitis Dermatitis, Atopic Eczema Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Pimecrolimus Tacrolimus Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Dermatologic Agents Immunosuppressive Agents Immunologic Factors Calcineurin Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |