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Sponsored by: |
University of Zurich |
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Information provided by: | University of Zurich |
ClinicalTrials.gov Identifier: | NCT00849368 |
Main Study Objectives:
The study is conducted to
Condition | Intervention | Phase |
---|---|---|
Inflammatory Bowel Disease |
Drug: Azathioprine / Allopurinol |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Dose-Effect Relationship Between Allopurinol, Azathioprine and 6-Thioguanine Nucleotide Levels (6-TGN) in Inflammatory Bowel Disease Patients. |
Estimated Enrollment: | 15 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Azathioprine / Allopurinol: Experimental
Single arm study: Dose escalations as described.
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Drug: Azathioprine / Allopurinol
Both drugs are applied orally. A pre-specified dose escalation regimen will be chosen. Azathioprine: Imurek (R) 50 mg and 25 mg tablets Allopurinol: Mephanol (R) 100 mg tablets |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Patients with a positive HIV testing (positive HIV 1 / 2 antibody tests)
Contact: 01 Studienregister MasterAdmins | +41 (0)44 255 11 11 | |
Contact: Alexander Jetter, MD | +41-44-255-9050 | alexander.jetter@usz.ch |
Switzerland | |
Division of Clinical Pharmacology and Toxicology, University Hospital Zurich | Recruiting |
Zurich, Switzerland, CH-8091 | |
Contact: Alexander Jetter, MD +41-44-255-9050 |
Study Director: | 01 Studienregister MasterAdmins | UniversitaetsSpital Zuerich |
Principal Investigator: | Alexander Jetter, MD | Division of Clinical Pharmacology and Toxicology, University Hospital Zürich, 8091 Zürich, Switzerland |
Responsible Party: | Division of Clinical Pharmacology & Toxicology, University Hospital Zürich ( Dr. med. Alexander Jetter, MD ) |
Study ID Numbers: | PHA-08-AZA/ALLO-01 |
Study First Received: | September 2, 2008 |
Last Updated: | June 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00849368 History of Changes |
Health Authority: | Switzerland: Swissmedic |
Antimetabolites Allopurinol Antioxidants Immunologic Factors Gastrointestinal Diseases Thioguanine Inflammatory Bowel Diseases |
Intestinal Diseases Immunosuppressive Agents Digestive System Diseases Azathioprine Gastroenteritis Antirheumatic Agents |
Antimetabolites Allopurinol Antimetabolites, Antineoplastic Antioxidants Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Physiological Effects of Drugs Inflammatory Bowel Diseases Enzyme Inhibitors |
Intestinal Diseases Immunosuppressive Agents Protective Agents Gout Suppressants Pharmacologic Actions Digestive System Diseases Azathioprine Therapeutic Uses Free Radical Scavengers Gastroenteritis Antirheumatic Agents |