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NCT00464997 Clinical Trial

The Effect of Low Dose Aspirin on the Pharmacokinetics of Methotrexate

Rheumatoid Arthritis Clinical Trial

Official title:
The Effect of Low Dose Aspirin on the Pharmacokinetics of Methotrexate

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00464997
Other study ID # TASMC-07-OE-156-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 23, 2007
Last updated April 23, 2007
Start date June 2007

Study information
Verified date April 2007
Source Tel-Aviv Sourasky Medical Center
Contact n/a
Is FDA regulated No
Health authority ISRAEL:TASMC MONITORING COMITTEE
Study type Observational

Clinical Trial Summary

High dose aspirin have been shown to increase the level of Methotrexat in patients with Rheumatoid Arthritis. However, most of RA patients are not currently treated with high dose aspirin. On the other hand, they frequently receive treatment with low dose aspirin. The effect of low dose aspirin on the levels of Methotrexate is not well known. Therefore,the purpose of this study is to assess the effect of low dose aspirin on the levels of methotrexate.

Description:

Thirty Rheumatoid Arthritis patients currently treated with low dose methotrexate (MTX) will participate in this study. On the day of intake of methotrexate, the patients will receive 10 mg of MTX. Serum levels of MTX will be measured at time 0,30 ,90, 120 minutes, and after 12 and 24 hours.

Two weeks later, the patients will be recommended to take 100 mg aspirin/d during a week. The levels of MTX will be measured after a week of treatment in a way similar to a week before.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- RApatients treated with Methotrexate

Exclusion Criteria:

- Contraindication to aspirin

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center
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