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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00980629
First Posted: September 21, 2009
Last Update Posted: November 3, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Maruho Co., Ltd.
  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
Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00980629     History of Changes
Other Study ID Numbers: M516102-EU03
First Submitted: July 24, 2009
First Posted: September 21, 2009
Last Update Posted: November 3, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Pruritus
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Manifestations
Signs and Symptoms