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A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis

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.
ClinicalTrials.gov Identifier: NCT00717769
Recruitment Status : Completed
First Posted : July 17, 2008
Last Update Posted : November 6, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of the study is to explore the efficacy and safety of SUN13834 vs placebo in adult subjects with atopic dermatitis

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: SUN13834 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis
Study Start Date : July 2008
Primary Completion Date : April 2009
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: SUN13834
Daily oral doses, low dose, for 28 days of SUN13834
Placebo Comparator: 2 Drug: Placebo
Daily oral doses, placebo, for 28 days of SUN13834


Outcome Measures

Primary Outcome Measures :
  1. Eczema Area and Severity Index (EASI) Score measured throughout the study [ Time Frame: throughout study ]

Secondary Outcome Measures :
  1. Investigator's Global Assessment measured throughout the study [ Time Frame: throughout study ]
  2. Pruritis score measured throughout the study [ Time Frame: throughout study ]
  3. Insomnia evaluation measured throughout the study [ Time Frame: throughout study ]
  4. Safety and tolerability data as measured by adverse events, electrocardiograms, serum biomarkers, clinical laboratory tests, and vital signs [ Time Frame: throughout study ]

Eligibility Criteria

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
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects between 18 and 65 years of age (inclusive).
  • A diagnosis of AD, meeting the Guidelines for Diagnosis of Atopic Dermatitis criteria

Exclusion Criteria:

  • Taking systemic immunosuppressive drugs or biologicals (within 3 months), or systemic corticosteroids therapy (within 4 weeks)prior to Screening(note: inhaled, intranasal or otic corticosteroids are allowed).
  • Use of phototherapy or tanning beds within 6 weeks of screening
  • History of reactive airway disease (asthma) requiring hospitalization in an intensive care unit in the last 5 years.
  • Presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the Clinical Investigator) that will interfere with interpretation of data from this patient (eg, renal impairment with non-atopic pruritis).
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): NCT00717769


  Show 28 Study Locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
More Information

Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00717769     History of Changes
Other Study ID Numbers: ASBI 404
First Posted: July 17, 2008    Key Record Dates
Last Update Posted: November 6, 2015
Last Verified: October 2015

Keywords provided by Daiichi Sankyo, Inc.:
Atopic Dermatitis

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