Dose-Finding Study of M516102 in the Treatment of Pruritus Associated With Atopic Dermatitis

Phase 2

Completed

• Conditions: Atopic Dermatitis

• Registration Number: NCT00980629
• Lead Sponsor: Maruho Co., Ltd.

Brief Summary

This study is to investigate the efficacy and safety of M516102 and to evaluate the dose response relationship of M516102 and placebo, in the treatment of pruritus associated with atopic dermatitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-09-18
• Study First Posted: 2009-09-21
• Study Completion: 2010-09
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-02
• Last Update Posted: 2010-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pruritus score

Trial Locations

Locations (4)

Hôpital Morvan; 🇫🇷 Brest, France

Samodzielny Publiczny Szpital Kliniczny Nr 1; 🇵🇱 Warsaw, Poland

Universitätsklinikum Münster; 🇩🇪 Munster, Germany

The Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, United Kingdom