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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00035074
First Posted: May 3, 2002
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Crohn's and Colitis Foundation
Information provided by:
National Center for Research Resources (NCRR)
  Purpose
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.

Condition Intervention
Inflammatory Bowel Disease Drug: Methotrexate

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Study to Determine the Oral Bioavailability of Methotrexate in Patients With Inflammatory Bowel Disease

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00035074


Locations
United States, Pennsylvania
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
National Center for Research Resources (NCRR)
Crohn's and Colitis Foundation
  More Information

ClinicalTrials.gov Identifier: NCT00035074     History of Changes
Other Study ID Numbers: NCRR-M01RR00240-1757
First Submitted: May 2, 2002
First Posted: May 3, 2002
Last Update Posted: December 9, 2005
Last Verified: December 2003

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors