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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

For Condition: Inflammatory Bowel Disease
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Crohn's and Colitis Foundation
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Crossover Assignment, Bio-availability Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

Childrens Hospital of Philadelphia
Philadelphia,  Pennsylvania,  19104
United States
 


Additional Information:
Study ID Numbers:
  NCRR-M01RR00240-1757; 
Study Start Date: 
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00035074

Other Inflammatory Bowel Disease Studies:
1. A Randomized Trial of Rosiglitazone for Ulcerative Colitis

2. A pharmacokinetic study to determine the oral bioavailability of methotrexate in patients with inflammatory bowel disease

3. Humanized anti-IL-2 receptor monoclonal antibody in moderate-to-severe ulcerative colitis

4. Immune Regulation in Ulcerative Colitis or Crohn's Disease

5. Clotrimazole Enemas for Pouchitis in Children and Adults

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A pharmacokinetic study to determine the oral bioavailability of methotrexate in patients with inflammatory bowel disease

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