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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00980629
• Other study ID #: M516102-EU03
• Status: Completed
• Phase: Phase 2
• First received: July 24, 2009
• Last updated: November 2, 2010
• Start date: August 2008
• Est. completion date: September 2010

Study information

• Verified date: November 2010
• Source: Maruho Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the EnvironmentCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Ministry of HealthPoland: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2010
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• M516102
Twice a day
• placebo
Twice a day

Locations

Country	Name	City	State
France	Hôpital Morvan	Brest
Germany	Universitätsklinikum Münster	Munster
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1	Warsaw
United Kingdom	The Royal Infirmary of Edinburgh	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
Maruho Co., Ltd.

Countries where clinical trial is conducted

France,  Germany,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pruritus score