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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00035074
Enrollment
Unknown
Registered
2002-05-03
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease

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.

Interventions

DRUGMethotrexate

Sponsors

Crohn's and Colitis Foundation
CollaboratorOTHER
National Center for Research Resources (NCRR)
Lead SponsorNIH

Study design

Intervention model
CROSSOVER
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026