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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00601107 |
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Date of registration:
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15/01/2008 |
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Primary sponsor: |
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Public title:
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A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Patients With Moderate to Severe Psoriasis
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Scientific title:
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A Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Efficacy and Safety of Doxercalciferol Capsules in the Treatment of Subjects Wtih Moderate to Severe Chronic Plaque Psoriasis. |
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Date of first enrolment:
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April 2008 |
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Target sample size:
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136 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00601107 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Genzyme |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subject must have moderate to severe chronic plaque psoriasis with a body surface
area (BSA) involvement =10%.
- Subject must have static PGA of moderate or severe.
- Subject must have a minimum PASI score of =10.
Exclusion Criteria:
- Use of drugs known to influence serum calcium (such as lithium, digoxin, thiazide
diuretics, teriparatide, bisphosphonates, and calcitonin) and multivitamin
supplements containing >400 IU vitamin D or calcium and/or calcium-containing
antacids exceeding a total of 1 gram/day.
- Use of other psoriasis medications or light therapy during the study except for
shampoos containing coal tar or salicylic acid and low potency topical
corticosteroids (Classes VI and VII) on the groin, scalp, palms, soles and face.
- History of kidney stones, chronic kidney disease, symptomatic coronary or cerebral
vascular disease, HIV, active viral hepatitis, or any other clinically significant,
unstable medical condition that would interfere with the completion of the study.
- Any evidence of active malignancy except for basal cell carcinoma of the skin. A
history of malignancy is not an exclusion.
- Active ethanol or drug abuse.
- Pregnant or breast-feeding women.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Moderate to Severe Chronic Plaque Psoriasis
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Intervention(s)
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Drug: doxercalciferol
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Drug: placebo
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Primary Outcome(s)
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Achievement of at least a 50% reduction in PASI score (PASI 50)
[Time Frame: at week 12]
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Secondary Outcome(s)
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Achievement of a static PGA score of clear (0) or almost clear (1)
[Time Frame: at week 12 and week 24]
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Achievement of PASI 50
[Time Frame: at week 24]
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Secondary ID(s)
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HECTPS02507
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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