- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00035074
A Pharmacokinetic Study to Determine the Oral Bioavailability of Methotrexate in Patients With Inflammatory Bowel Disease
June 23, 2005 updated by: National Center for Research Resources (NCRR)
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.
Study Overview
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Childrens Hospital of Philadelphia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Crossover Assignment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
May 2, 2002
First Submitted That Met QC Criteria
May 2, 2002
First Posted (Estimate)
May 3, 2002
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
December 1, 2003
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Inflammatory Bowel Diseases
- Intestinal Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
Other Study ID Numbers
- NCRR-M01RR00240-1757
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of ChicagoTerminatedInflammatory Bowel Disease (IBD)United States
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University of Wisconsin, MadisonTerminatedInflammatory Bowel Disease (IBD)United States
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Cairo UniversityCompleted
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CHA UniversityCompleted
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