Dose Ranging Study of the Safety and Efficacy of R115966 in Plaque Psoriasis
NCT ID: NCT00716144
Last Updated: 2018-01-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
176 participants
INTERVENTIONAL
2006-06-01
2007-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
Talarozole 0.5 mg
Talarozole
Oral Capsule Once Daily
B
Talarozole 1.0 mg
Talarozole
Oral Capsule Once Daily
C
Talarozole 2.0 mg
Talarozole
Oral Capsule Once Daily
D
Talarozole matching Placebo
Talarozole
Oral Capsule Once Daily
Interventions
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Talarozole
Oral Capsule Once Daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or a female who was NOT of childbearing potential (i.e., post- menopausal for greater than 12 months or had a complete hysterectomy);
Exclusion Criteria
* Guttate, pustular, erythrodermic, or other non-plaque form of psoriasis
* Subject was under treatment for a heart disorder or had a history of cardiovascular disease (excluding effectively controlled hypertension)
* Any acute psychiatric condition, including an increased risk for suicide attempt, based on medical and psychiatric history
* Previous use of a psoriasis vaccine or had participated in an investigational study of a psoriasis vaccine
* Previous use of systemic immunomodulatory therapy known to affect psoriasis and to typically decrease immune cell populations
* Previous use of any systemic immunomodulatory therapy known to affect psoriasis and NOT typically to decrease immune cell populations
* Previous use of any photo-therapy (including laser), photo-chemotherapy, or systemic psoriasis therapy (such as systemic corticosteroids, methotrexate, retinoids, or cyclosporine) within the previous four weeks
* Pregnant or a nursing mother
* Significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic pancreatitis, osteoporosis, cancer (except non-melanoma skin cancer), a positive test for human immunodeficiency virus (HIV), a history indicating adrenal cortex dysfunction
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Stiefel, a GSK Company
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Augsburg, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Dresden, , Germany
GSK Investigational Site
Frankfurt, , Germany
GSK Investigational Site
Hamburg, , Germany
GSK Investigational Site
Salzwedel, , Germany
GSK Investigational Site
Cork, , Ireland
GSK Investigational Site
Maastricht, , Netherlands
GSK Investigational Site
Nijmegen, , Netherlands
GSK Investigational Site
Korolyov, , Russia
GSK Investigational Site
Lipetsk, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Saint Petersburg, , Russia
GSK Investigational Site
Smolensk, , Russia
GSK Investigational Site
Veliky Novgorod, , Russia
GSK Investigational Site
Yaroslavl, , Russia
GSK Investigational Site
Aberdeen, , United Kingdom
GSK Investigational Site
Amersham, , United Kingdom
GSK Investigational Site
Coventry, , United Kingdom
GSK Investigational Site
Glasgow, , United Kingdom
GSK Investigational Site
Manchester, , United Kingdom
GSK Investigational Site
Norwich, , United Kingdom
Countries
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Other Identifiers
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BT0720-201-INT
Identifier Type: -
Identifier Source: org_study_id
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