ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
A Pharmacokinetic Study to Determine the Oral Bioavailability of Methotrexate in Patients With Inflammatory Bowel Disease

This study has been completed.

Sponsors and Collaborators: National Center for Research Resources (NCRR)
Crohn's and Colitis Foundation
Information provided by: National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier: NCT00035074
  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

Genetics Home Reference related topics:   Crohn disease   

ChemIDplus related topics:   Methotrexate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Crossover Assignment, Bio-availability Study
Official Title:   A Pharmacokinetic Study to Determine the Oral Bioavailability of Methotrexate in Patients With Inflammatory Bowel Disease
  Eligibility
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers:   NCRR-M01RR00240-1757
First Received:   May 2, 2002
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00035074
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Folic Acid
Digestive System Diseases
Gastrointestinal Diseases
Methotrexate
Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 28, 2008




Links to all studies - primarily for crawlers