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NCT00601107 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe Psoriasis

A Phase 2 study of Moderate-to-severe Chronic Plaque Psoriasis, sponsored by Genzyme, a Sanofi Company.

Completed
Registry status
Phase 2
Development phase
111
Enrollment target
19
Study locations

NCT00601107: Completed Phase 2 study of Moderate-to-severe Chronic Plaque Psoriasis, sponsored by Genzyme, a Sanofi Company.

NCT00601107 is a Phase 2 study of Moderate-to-severe Chronic Plaque Psoriasis that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 111 participants, below the 191-participant average among 3 other Moderate-to-severe Chronic Plaque Psoriasis trials with a reported enrollment target (42% lower). The trial reports 19 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00601107, a Phase 2 study of Moderate-to-severe Chronic Plaque Psoriasis, has completed, sponsored by Genzyme, a Sanofi Company.

COMPLETED
Registry status
Phase 2
Development phase
111 participants
Enrollment target
19
Study locations

Study Summary

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

Primary Outcome

PASI score: range: 0 (no disease) to 72 (maximal disease). Body was divided into head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent area of skin involved (A) was estimated: 1 (\<10%) to 6 (90% - 100%), and severity was estimated by clinical signs: (erythema \[E\], induration \[I\], and desquamation \[D\]) on a scale: 0=no symptoms, 4=very marked. PASI score= 0.1 (E\[h\] + I\[h\] + D\[h\]) A\[h\] + 0.2 (E\[u\] + I\[u\] + D\[u\]) A\[u\] + 0.3 (E\[t\] + I\[t\] + D\[

Conditions Studied

Moderate-to-severe Chronic Plaque Psoriasis

Interventions

  • DRUG Placebo
  • DRUG Doxercalciferol

Study Locations (19)

California

  • - Irvine
  • - Santa Monica

Massachusetts

  • - Andover
  • - Boston

Michigan

  • - Troy
  • - West Bloomfield

Alabama

  • - Birmingham

Arizona

  • - Hot Springs

Arkansas

  • - Little Rock

Georgia

  • - Alpharetta

Indiana

  • - Indianapolis

Trial Details

FieldValue
Enrollment Target 111 participants
Start Date 2008-04
Est. Completion 2009-06
Phase Phase 2
Genzyme, a Sanofi Company

196 total trials

What the finished NCT00601107 record still lists

NCT00601107 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 191-participant average among 3 other Moderate-to-severe Chronic Plaque Psoriasis trials with a reported enrollment target (42% lower).

The record links to 1 condition, with Moderate-to-severe Chronic Plaque Psoriasis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00601107 lists 19 locations in 16 states (California, Massachusetts, Michigan).

Frequently Asked Questions

What is clinical trial NCT00601107 about?

NCT00601107 is a clinical study titled "A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe Psoriasis". The purpose of this study was to evaluate the safety and effectiveness of an investigational drug called doxercalciferol in participants with moderate to severe chronic plaque psoriasis, in comparison with a placebo ("sugar pill"). All study related care was provided including doctor visits, physica...

What is the current status of trial NCT00601107?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 111 participants. The study started on 2008-04. Estimated completion is 2009-06.

What conditions does trial NCT00601107 study?

This clinical trial studies the following conditions: Moderate-to-severe Chronic Plaque Psoriasis.

What interventions are being tested in trial NCT00601107?

The interventions under investigation include: Placebo (DRUG), Doxercalciferol (DRUG).

Who is sponsoring clinical trial NCT00601107?

This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00601107 being conducted?

This trial has 19 study locations across Alabama, Arizona, Arkansas, California, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT00601107, the US trial registry maintained by the National Library of Medicine. NCT00601107 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.