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

NCT00980629 | Completed Phase 2

• 1 other identifier: M516102-EU03
• Study Type: interventional
• Target: N/A
• Locations: 4 countries
• Sites: 4

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Pruritus score

Interventions

M516102 DRUG

Twice a day

placebo DRUG

Twice a day

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients (aged 18-65 years) with a diagnosis of AD.
• Female patients of child bearing potential must be using a medically acceptable form of contraception.
• Patients who are able and willing to give signed informed consent.
• Patients who have pruritus exceed the reference range.

You may not qualify if:

• Patients who have a history of allergy to hydrocortisone.
• Patients who have a history of relevant drug hypersensitivity.
• Patients who have a history of contact dermatitis induced by a topical steroid.
• 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.
• Patients who have a history or presence of any cancer.
• Patients who have any renal or liver insufficiency, or clinically significant cardiac, renal or hepatic disease.
• Patients who, in the opinion of the investigator, are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
• Patients who have pruritus associated with conditions other than AD.
• Patients who have pruritus only on the face and head.
• 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.
• Patients who have used M5161(active ingredient of M516102).
• Patients who cannot communicate reliably with the investigator.
• Patients who are pregnant or lactating.
• Patients who have used any IMP and/or participated in any clinical trial within 3 months.

Sponsors & Collaborators

• Maruho Co., Ltd.: lead

Study Sites (4)

Hôpital Morvan

Brest, 29609, France

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1

Warsaw, 50-368, Poland

Location

The Royal Infirmary of Edinburgh

Edinburgh, EH3 9YW, United Kingdom

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 24, 2009
• First Posted: September 21, 2009
• Study Start: August 1, 2008
• Study Completion: September 1, 2010
• Last Updated: November 3, 2010

Record last verified: 2010-11

Locations

FR (1); DE (1); GB (1); PL (1)