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

This study has been completed.

First Received on May 2, 2002. Last Updated on June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	Crohn's and Colitis Foundation
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00035074

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:

Genetics Home Reference related topics: Crohn disease

Drug Information available for: Methotrexate

U.S. FDA Resources

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035074

Locations

United States, Pennsylvania
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Crohn's and Colitis Foundation

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 February 12, 2012