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Sponsored by: |
Shionogi USA, Inc. |
---|---|
Information provided by: | Shionogi USA, Inc. |
ClinicalTrials.gov Identifier: | NCT00703573 |
Study consists of three treatment groups of 75 patients with atopic dermatitis. Treatment Group A: 400 mg BID of S-777469 Treatment Group B: 800 mg BID of S-777469 Treatment Group C: Placebo
The primary objective of the study is to evaluate the safety and efficacy of S-777469.
Condition | Intervention | Phase |
---|---|---|
Atopic Dermatitis |
Drug: S-777469 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Two Doses of S-777469 (400 mg BID and 800 mg BID) in Patients With Atopic Dermatitis |
Estimated Enrollment: | 225 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
400 mg BID
|
Drug: S-777469
S-777469 400 mg BID
|
2: Experimental
800 mg BID
|
Drug: S-777469
S-777469 800 mg BID
|
3: Placebo Comparator
Placebo
|
Drug: Placebo
Placebo
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Screening Inclusion Criteria:
Randomization Inclusion Criteria:
Patient satisfies all of the following at the end of the Single-blind Period (just before randomization to study drug):
Use of adequate birth control, if of reproductive potential and sexually active. Adequate birth control is defined as agreement to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 2 weeks after last administration/dose of study drug
Patient has NOT used any treatments for AD prior to Day 1, using the following time periods:
1. Use of cosmetic make-up will be allowed.
Exclusion Criteria:
Presence of comorbid conditions that would preclude participation in the study, including:
NOTE: Under no circumstances should a patient who did not qualify regarding Liver Function Tests (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] be re-screened and/or re-qualified.
Contact: Sandra A Davis | 201 587 0500 ext 3374 | sdavis@tklresearch.com |
Study Chair: | Richard A Paul, MD | Shionogi USA, Inc. |
Responsible Party: | Shionogi USA, Inc. ( Gareth Morgan / VP Project Management ) |
Study ID Numbers: | 0721D1424 |
Study First Received: | June 20, 2008 |
Last Updated: | June 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00703573 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Atopic Dermatitis |
Hypersensitivity Dermatitis, Atopic Genetic Diseases, Inborn Skin Diseases |
Hypersensitivity, Immediate Skin Diseases, Eczematous Skin Diseases, Genetic Dermatitis |
Hypersensitivity Dermatitis, Atopic Immune System Diseases Genetic Diseases, Inborn Skin Diseases |
Hypersensitivity, Immediate Skin Diseases, Eczematous Skin Diseases, Genetic Dermatitis |