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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00206596 |
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Date of registration:
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12/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study in Patients With Crohn's Disease Who Are Steroid Dependent, Despite Previous Unsuccessful Attempts to Reduce Steroids Due to Worsening of Crohn's Disease
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Scientific title:
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Randomized, Stratified, Double-Blind, Placebo-Controlled Phase 2 Study of Steroid-Sparing Properties of Sargramostim (Leukine) Therapy in Patients With Cortico-Dependent Crohn's Disease |
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Date of first enrolment:
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July 2003 |
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Target sample size:
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127 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00206596 |
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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, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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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, a Sanofi Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- You must have active Crohn's disease at screening and been diagnosed with Crohn's
disease within 6 months at screening.
- You must have steroid dependent disease (receiving between 10-40 mgs/day prednisone
therapy for greater than 3 months prior to screening and had at least one
unsuccessful attempt to reduce cortico-steroids due to worsening of disease).
- You must be able to give yourself an injection of study drug or have another person
help you give the injection.
- You must not be pregnant and agree to use birth control if you are a sexually active
male or female of childbearing potential.
Exclusion Criteria:
- You may not be taking medications not allowed on this study.
- You may not have had GI surgery or bowel obstruction in the last 6 months.
- You may not have ever taken this drug or drugs of similar type in the past.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crohn Disease
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Intervention(s)
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Drug: Sargramostim (Leukine)
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Drug: Placebo
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Primary Outcome(s)
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Corticosteroid-free remission
[Time Frame: At the end of the study treatment]
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Secondary Outcome(s)
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Quality of Life using Inflammatory Bowel Disease Questionaire, SF 36 and EuroQol-derived visual scale (VAS)
[Time Frame: At the end of the study treatment]
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Steroid-free remission or response to treatment as defined by the protocol
[Time Frame: At the end of the study treatment]
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Secondary ID(s)
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307501
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91282
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Novel 2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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