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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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8 April 2013 |
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Main ID: |
NCT00198081 |
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Date of registration:
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12/09/2005 |
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Primary sponsor: |
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Public title:
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Use of Celecoxib in Patients With Intraductal Papillary Mucinous Neoplasms (IPMNs)
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Scientific title:
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A Phase II Trial of Celecoxib in Patients With IPMN |
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Date of first enrolment:
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September 2005 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00198081 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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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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Christian M. Schmidt, MD |
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Address:
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Telephone:
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317-278-8349 |
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Email:
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maxschmi@iupui.edu |
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Affiliation:
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Name:
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Christian M. Schmidt, MD |
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Address:
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Telephone:
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(317) 278-8349 |
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Email:
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maxschmi@iupui.edu |
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Affiliation:
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Name:
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Christian M. Schmidt, 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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Indiana University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical diagnosis of IPMN
- ECOG Performance status of 0, 1, or 2
- Adequate liver function, bilirubin < 1.5 times ULN, ALT or AST < 2.5 times ULN
- Adequate renal function: creatinine < 1.8
- Must be at least 18
Exclusion Criteria:
- Use of COX-2 selective inhibitors within the last month
- More than occasional use of NSAIDS in last month (occasional use defined as up to
twice weekly dosing)
- CA19-9 levels 1.5 times the ULN
- Active pancreatitis
- Taking sulphonylureas, fluconazole or lithium concomitantly
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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Pancreas Neoplasms
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Intervention(s)
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Drug: celecoxib
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Primary Outcome(s)
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Determine whether the COX-2 inhibitor celecoxib changes the IPMN tumor marker profile in serum, pancreatic fluid and tissue of patients with IPMN through gene and protein expression profiling studies.
[Time Frame: 1 year]
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Secondary Outcome(s)
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Determine whether the COX-2 inhibitor celecoxib changes IPMN progression clinically.
[Time Frame: 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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