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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00980629 |
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Date of registration:
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24/07/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Dose-Finding Study of M516102 in the Treatment of Pruritus Associated With Atopic Dermatitis
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Scientific title:
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A Randomized, Placebo-Controlled, Double-blind, Parallel Group, Multi-centre Phase II Dose-Finding Study of M516102 in the Treatment of Pruritus Associated With Atopic Dermatitis |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00980629 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind
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Phase:
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Phase 2
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Countries of recruitment
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France
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Germany
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Poland
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Male or female patients (aged 18-65 years) with a diagnosis of AD.
2. Female patients of child bearing potential must be using a medically acceptable form
of contraception.
3. Patients who are able and willing to give signed informed consent.
4. Patients who have pruritus exceed the reference range.
Exclusion Criteria:
1. Patients who have a history of allergy to hydrocortisone.
2. Patients who have a history of relevant drug hypersensitivity.
3. Patients who have a history of contact dermatitis induced by a topical steroid.
4. Patients who are taking, and who are unwilling not to take, any medications or
therapy prohibited by the protocol for the complete duration of the study.
5. Patients who have a history or presence of any cancer.
6. Patients who have any renal or liver insufficiency, or clinically significant
cardiac, renal or hepatic disease.
7. Patients who, in the opinion of the investigator, are not deemed eligible as
determined by medical history, physical examination or clinical laboratory safety
tests.
8. Patients who have pruritus associated with conditions other than AD.
9. Patients who have pruritus only on the face and head.
10. Patients who, in the opinion of the investigator, have clinically relevant history
or presence of any disease, or surgical history other than AD which is likely to
affect the conduct of the study.
11. Patients who have used M5161(active ingredient of M516102).
12. Patients who cannot communicate reliably with the investigator.
13. Patients who are pregnant or lactating.
14. Patients who have used any IMP and/or participated in any clinical trial within 3
months.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atopic Dermatitis
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Intervention(s)
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Drug: placebo
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Drug: M516102
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Primary Outcome(s)
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Pruritus score
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Secondary ID(s)
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M516102-EU03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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