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NCT00035074 Clinical Trial

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

Inflammatory Bowel Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00035074
Other study ID # NCRR-M01RR00240-1757
Secondary ID
Status Completed
Phase N/A
First received May 2, 2002
Last updated June 23, 2005

Study information
Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility - 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 Design

Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Methotrexate

Locations
Country Name City State
United States Childrens Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Crohn's and Colitis Foundation

Country where clinical trial is conducted

United States, 

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