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A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Patients With Moderate to Severe Psoriasis
This study has been completed.
Study NCT00601107   Information provided by Genzyme
First Received: January 15, 2008   Last Updated: August 20, 2009   History of Changes

January 15, 2008
August 20, 2009
April 2008
February 2009   (final data collection date for primary outcome measure)
Achievement of at least a 50% reduction in PASI score (PASI 50) [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00601107 on ClinicalTrials.gov Archive Site
  • Achievement of PASI 50 [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Achievement of a static PGA score of clear (0) or almost clear (1) [ Time Frame: at week 12 and week 24 ] [ Designated as safety issue: No ]
Same as current
 
A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Patients With Moderate to Severe Psoriasis
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.

The aim of this study is to evaluate the safety and effectiveness of an investigational drug called doxercalciferol in patients with moderate to severe chronic plaque psoriasis, in comparison with a placebo ("sugar pill"). All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is 28 weeks.

This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging, parallel group study to evaluate the efficacy and safety of doxercalciferol given orally, once daily for 24 weeks to patients with moderate to severe chronic plaque psoriasis. Subjects will be randomized and stratified by site and Psoriasis Area Severity Index (PASI) score to one of three active treatment groups or to the placebo group.

Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Moderate to Severe Chronic Plaque Psoriasis
  • Drug: doxercalciferol
  • Other: N/A - placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
136
June 2009
February 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00601107
Medical Monitor, Genzyme Corporation
HECTPS02507
Genzyme
 
Study Director: Medical Monitor Genzyme
Genzyme
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP