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

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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: M516102; Drug: placebo

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • Hôpital Morvan
• Germany
  • Munster, Germany, 48149
    • Universitätsklinikum Münster
• Poland
  • Warsaw, Poland, 50-368
    • Samodzielny Publiczny Szpital Kliniczny Nr 1
• United Kingdom
  • Edinburgh, United Kingdom, EH3 9YW
    • The Royal Infirmary of Edinburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pruritus score

Collaborators and Investigators

• Sponsor: Maruho Co., Ltd.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Study Completion: September 1, 2010

Study Registration Dates

• First Submitted: July 24, 2009
• First Submitted That Met QC Criteria: September 18, 2009
• First Posted (ESTIMATE): September 21, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): November 3, 2010
• Last Update Submitted That Met QC Criteria: November 2, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Manifestations; Skin Diseases, Eczematous; Dermatitis; Eczema; Pruritus; Dermatitis, Atopic
• Other Study ID Numbers: M516102-EU03