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

This study has been completed.
Sponsor:
Information provided by:
Maruho Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00980629
First received: July 24, 2009
Last updated: November 2, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Drug: M516102
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Maruho Co., Ltd.:

Primary Outcome Measures:
  • Pruritus score

Study Start Date: August 2008
Estimated Study Completion Date: September 2010
Intervention Details:
    Drug: M516102
    Twice a day
    Drug: placebo
    Twice a day
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00980629

Locations
France
Hôpital Morvan
Brest, France, 29609
Germany
Universitätsklinikum Münster
Munster, Germany, 48149
Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1
Warsaw, Poland, 50-368
United Kingdom
The Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH3 9YW
Sponsors and Collaborators
Maruho Co., Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00980629     History of Changes
Other Study ID Numbers: M516102-EU03
Study First Received: July 24, 2009
Last Updated: November 2, 2010
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ministry of Health
Poland: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Dermatitis, Atopic
Dermatitis
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014