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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: |
NCT00774982 |
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Date of registration:
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16/10/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pilot Comparative Bioavailability Study of 6Mercaptopurine (Delayed Release vs. Purinethol) in Crohns Disease Patients
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Scientific title:
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Pilot, Randomized, Open-Label, Two-Way Crossover Comparative Bioavailability Study of 40 mg Delayed Release Oral 6Mercaptopurine Versus 100 mg Purinethol in Patients With Crohns Disease |
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Date of first enrolment:
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December 2008 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00774982 |
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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: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor)
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Phase:
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Phase 1
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Countries of recruitment
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Israel
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Contacts
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Name:
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Yaron Ilan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hadassah Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 12 male and non-pregnant females, aged 18-50 years, with Crohns Disease (CDAI up to
200), non-smoking.
Crohns Disease diagnosis via colonoscopy with biopsy within the past 12 years No CD
medications allowed during study other than 5-ASA and symptomatic relief (anti-diarrheals)
Screening lab tests: HGB>= 8.5 g/dl, platelets >= 100,000/mm3, WBC: 3500-12000/mm3, serum
albumin above 2.5 g/dl, amylase, lipase and total bilirubin within normal limits; ALT,
AST, alkaline phosphatase up to 1.5 x normal limits
Exclusion Criteria:
- No more than 2 bowel movements/24 hour period in week prior to screening No patients
on methotrexate, cyclosporine, or other anti-TNF alpha, or anti-neoplastics within 3
months of study start NO fistulizing CD or isolated small bowle CD No symptomatic
stenosis or ileal strictures,or x-ray evidnece of fibrosed bowel
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crohns Disease
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Intervention(s)
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Drug: 6 Mercaptopurine
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Drug: Delayed Release 6 mercaptopurine
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Primary Outcome(s)
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PK parameters: AUC, Cmax and Tmax
[Time Frame: Following single dose of test or reference drug]
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Secondary Outcome(s)
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FACS analysis of peripheral blood lymphocytes following single dose of test vs. reference formulation
[Time Frame: Comparison of values from blood collected at 0, 12 and 24 hours post-dose]
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Secondary ID(s)
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C1/13/6MP-02
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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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