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Sponsored by: |
Taisho Pharmaceutical R&D Inc. |
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Information provided by: | Taisho Pharmaceutical R&D Inc. |
ClinicalTrials.gov Identifier: | NCT00914186 |
The purpose and (primary) objectives of this study are to evaluate the efficacy, safety, and tolerability of TS-022 in adults with atopic dermatitis who have moderate to very severe pruritus (itching), following a 28-day regimen of twice-daily topical application.
Condition | Intervention | Phase |
---|---|---|
Atopic Dermatitis Moderate to Very Severe Pruritus |
Drug: TS022 Drug: Vehicle |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study of the Efficacy, Safety and Tolerability of TS-022 in Adult Patients With a Diagnosis of Atopic Dermatitis (AD) With Moderate to Very Severe Pruritus |
Estimated Enrollment: | 240 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
TS022: Experimental |
Drug: TS022
Lotion
|
Vehicle: Placebo Comparator |
Drug: Vehicle
Lotion
|
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Monica Williams | 484-991-8021 | mwilliams@clinsys.com |
United States, California | |
Recruiting | |
Fremont, California, United States, 94538 | |
Recruiting | |
La Jolla, California, United States, 92037 | |
United States, Florida | |
Recruiting | |
Kissimmee, Florida, United States, 34741 | |
Recruiting | |
Ormond Beach, Florida, United States, 32174 | |
United States, Georgia | |
Recruiting | |
Snellville, Georgia, United States, 30078 | |
United States, Kentucky | |
Recruiting | |
Louisville, Kentucky, United States, 40202 | |
United States, Minnesota | |
Recruiting | |
Fridley, Minnesota, United States, 55432 | |
United States, New Jersey | |
Recruiting | |
Berlin, New Jersey, United States, 08009 | |
United States, North Carolina | |
Recruiting | |
Raleigh, North Carolina, United States, 27612 | |
Recruiting | |
Winston-Salem, North Carolina, United States, 27157 | |
United States, Ohio | |
Recruiting | |
South Euclid, Ohio, United States, 44118 | |
United States, Oregon | |
Recruiting | |
Portland, Oregon, United States, 97239 | |
United States, Texas | |
Recruiting | |
College Station, Texas, United States, 77845 | |
Recruiting | |
Houston, Texas, United States, 77030 | |
Recruiting | |
Webster, Texas, United States, 77598 |
Responsible Party: | Taisho Pharmaceutical R&D Inc. |
Study ID Numbers: | TS022-US201 |
Study First Received: | May 28, 2009 |
Last Updated: | June 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00914186 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Atopic Dermatitis Pruritus |
Pruritus Signs and Symptoms Hypersensitivity Dermatitis, Atopic Genetic Diseases, Inborn |
Skin Diseases Hypersensitivity, Immediate Skin Diseases, Eczematous Skin Diseases, Genetic Dermatitis |
Pruritus Signs and Symptoms Skin Manifestations Hypersensitivity Dermatitis, Atopic Immune System Diseases |
Genetic Diseases, Inborn Skin Diseases Hypersensitivity, Immediate Skin Diseases, Eczematous Skin Diseases, Genetic Dermatitis |