Dose-Finding Study of M516102 in the Treatment of Pruritus Associated With Atopic Dermatitis
NCT ID: NCT00980629
Last Updated: 2010-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2008-08-31
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
DOUBLE
Interventions
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M516102
Twice a day
placebo
Twice a day
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Maruho Co., Ltd.
INDUSTRY
Locations
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Hôpital Morvan
Brest, , France
Universitätsklinikum Münster
Münster, , Germany
Samodzielny Publiczny Szpital Kliniczny Nr 1
Warsaw, , Poland
The Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Countries
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Other Identifiers
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M516102-EU03
Identifier Type: -
Identifier Source: org_study_id