A Pharmacokinetic Study to Determine the Oral Bioavailability of Methotrexate in Patients With Inflammatory Bowel Disease

This study has been completed.
Sponsor:
Collaborator:
Crohn's and Colitis Foundation
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00035074
First received: May 2, 2002
Last updated: June 23, 2005
Last verified: December 2003

May 2, 2002
June 23, 2005
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Complete list of historical versions of study NCT00035074 on ClinicalTrials.gov Archive Site
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A Pharmacokinetic Study to Determine the Oral Bioavailability of Methotrexate in Patients With Inflammatory Bowel Disease
A Pharmacokinetic Study to Determine the Oral Bioavailability of Methotrexate in Patients With Inflammatory Bowel Disease

Patients with inflammatory bowel disease (IBD) who require methotrexate (MTX)for treatment currently receive this drug by injection. MTX is also available as a pill that can be given by mouth but it is not known how well the drug enters the body in patients with Crohn's disease or ulcerative colitis. This study is being done to compare how much MTX enters the body when the drug is taken by mouth compared to when it is given by injection. If the drug is well absorbed, it may allow patients to receive the drug by mouth.

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Interventional
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Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Inflammatory Bowel Disease
Drug: Methotrexate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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  • Adult or pediatric patients with IBD (CD or UC) currently receiving MTX as part of their clinical care.
  • Patients must be receiving weekly MTX at a dose between 7.5 and 40 mg/m2.
  • Weight >= 12 kg.
  • Normal serum creatinine.
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00035074
NCRR-M01RR00240-1757
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National Center for Research Resources (NCRR)
Crohn's and Colitis Foundation
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National Center for Research Resources (NCRR)
December 2003

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