A Pharmacokinetic Study to Determine the Oral Bioavailability of Methotrexate in Patients With Inflammatory Bowel Disease
This study has been completed.
Sponsor:
Collaborator:
Crohn's and Colitis Foundation
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00035074
First received: May 2, 2002
Last updated: June 23, 2005
Last verified: December 2003
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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 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Primary Purpose: Treatment |
| Official Title: | A Pharmacokinetic Study to Determine the Oral Bioavailability of Methotrexate in Patients With Inflammatory Bowel Disease |
Resource links provided by NLM:
Further study details as provided by National Center for Research Resources (NCRR):
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 More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00035074 History of Changes |
| Other Study ID Numbers: | NCRR-M01RR00240-1757 |
| Study First Received: | May 2, 2002 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Inflammatory Bowel Diseases Intestinal Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013