Back to resultsA Pharmacokinetic Study to Determine the Oral Bioavailability of Methotrexate in Patients With Inflammatory Bowel Disease
Primary Purpose
Inflammatory Bowel Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Disease
Eligibility 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.
Sites / Locations
- Childrens Hospital of Philadelphia
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00035074
First Posted
May 2, 2002
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
Crohn's and Colitis Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00035074
Brief Title
A Pharmacokinetic Study to Determine the Oral Bioavailability of Methotrexate in Patients With Inflammatory Bowel Disease
Official Title
A Pharmacokinetic Study to Determine the Oral Bioavailability of Methotrexate in Patients With Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
Crohn's and Colitis Foundation
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Methotrexate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Childrens Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pharmacokinetic Study to Determine the Oral Bioavailability of Methotrexate in Patients With Inflammatory Bowel Disease
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