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The Effect of Low Dose Aspirin on the Pharmacokinetics of Methotrexate

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00464997
First received: April 23, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: The Effect of Low Dose Aspirin on the Pharmacokinetics of Methotrexate

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Estimated Enrollment: 30
Study Start Date: June 2007
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • RApatients treated with Methotrexate

Exclusion Criteria:

  • Contraindication to aspirin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00464997

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Ori Elkayam, M.D Tel Aviv Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00464997     History of Changes
Other Study ID Numbers: TASMC-07-OE-156-CTIL
Study First Received: April 23, 2007
Last Updated: April 23, 2007
Health Authority: ISRAEL:TASMC MONITORING COMITTEE

Keywords provided by Tel-Aviv Sourasky Medical Center:
methotrexate aspirin pharmacokinetics

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Aspirin
Methotrexate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013