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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 1, 2007 | ||||
| Last Updated Date | September 18, 2009 | ||||
| Start Date ICMJE | March 2007 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Evaluate safety and efficacy of oral doses of JNJ-26113100 for 6 weeks; assessing adverse events, vital signs, laboratory findings, physical exams, electrocardiograms and accepted atopic dermatitis clinical measures in adults with atopic dermatitis | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00455429 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Evaluate how the body processes JNJ-26113100 over time as well as the effects of JNJ-26113100 on inflammatory markers at following visits: randomization, week 1, week 3, week 6 and week 8. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study of the Safety and Efficacy of JNJ-26113100 in the Treatment of Adult Atopic Dermatitis | ||||
| Official Title ICMJE | A Double-Blind, Randomized, Placebo-Controlled, Sequential Cohort Exploratory Study of the Safety and Efficacy of JNJ-26113100 in the Treatment of Adult Atopic Dermatitis That is Moderate in Severity | ||||
| Brief Summary | The purpose of this study is to evaluate the safety and effectiveness of oral administration of four dose regimens of JNJ-26113100 prepared in a capsule formulation administered for 6 weeks in the treatment of adult atopic dermatitis that is moderate in severity. |
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| Detailed Description | A multi-center, exploratory study will be done to evaluate the safety and effectiveness of JNJ-26113100 in the treatment of adult atopic dermatitis, including its effect on biomarkers. Approximately 140 adults with atopic dermatitis will take part in the study. After screening, they will be randomly (patients are assigned different treatments based on chance) assigned to one of four treatment groups in a sequential fashion to receive JNJ-26113100 50 mg once daily, 100 mg once daily, 100 mg twice daily or 250 mg twice daily or matching placebo. Study medication will be dispensed in a blinded fashion. The patient, the study doctor and the study sponsor will not know the treatment to which the patient has been assigned. The first dose will be administered in the clinic. Depending on the treatment group, patients will take medication either once or twice daily for six weeks. Study visits will be conducted at the end of Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. A study termination visit will be conducted at the end of Week 8. The patient's skin will be assessed at following visits: screening, randomization, week 1, week 2, week 3, week 4, week 5, week 6 and at study termination. Medical history, physical examination, blood pressure, heart rate, respiratory rate, temperature and electrocardiograms will be checked periodically during the study. Blood and urine samples will be collected for standard safety laboratory tests, to measure the level of drug and to learn about the effect of the drug on markers of inflammation. Two skin biopsies from atopic dermatitis lesions will be collected during the study to assess changes in the inflammatory disease state. Patients developing flares of their disease may be treated with triamcinolone acetonide 0.1% ointment twice daily for up to 7 days. Patients will receive JNJ-26113100 50 mg once daily, 100 mg once daily, 100 mg twice daily or 250 mg twice daily or matching placebo capsules for 6 weeks. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Atopic Dermatitis | ||||
| Intervention ICMJE | Drug: JNJ-26113100 | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 82 | ||||
| Completion Date | March 2009 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00455429 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CR012946 | ||||
| Study Sponsor ICMJE | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | ||||
| Verification Date | September 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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