Study to Evaluate Eye Function in Patients Taking Linezolid for Two Months or Greater - NCT00359632-19140 (Clinical Trial 147415)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy147415.aspx
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| City: |
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Philadelphia |
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State:
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PA |
| Zip Code: |
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19140 |
| Conditions: |
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Optic Nerve Diseases |
| Purpose: |
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To understand and characterize the effects of linezolid on the optic nerve by observing and
following patients who have been treated with linezolid for two months or longer for the
development of signs or symptoms of visual disturbance or eye disorders
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| Study summary: |
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Characterize Optic Side Effect |
| Criteria: |
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Inclusion Criteria:
- Male and female subjects who are 18 years of age or older.
- Subjects in Treated Group:
- Subjects must have received linezolid 600 mg BID for two months or greater and be
currently on drug (or have received linezolid within 7 days of baseline evaluation).
- Subjects who have current signs or symptoms compatible with linezolid toxicity (i.e.
optic or peripheral neuropathy) may be enrolled in the study if they are on linezolid
at time of baseline evaluation (or have received linezolid within 7 days of baseline
evaluation).
- Linezolid may be discontinued at any time at the primary physician's discretion and
remain on the study.
- Women of childbearing potential must use adequate contraception
- Subjects in Control Group:
- Subjects will have a diagnosis similar to patients in the treated group and similar
important co-morbidities and epidemiologic factors if possible.
Exclusion Criteria:
- Subject in Treated Group:
- Subjects with a known presence of optic or peripheral nerve damage due to another
illness, condition or medication.
- Subjects with a pre-existing or a diagnosis at time of screening visit of an
ophthalmologic condition that would adversely affect the study testing protocol (e.g.
dense cataracts, macular degeneration, retinitis pigmentosa).
- Subjects who are currently receiving or anticipated to receive another medication,
antibiotic or other, that has known potential to produce ocular or neurologic
toxicity or lactic acidosis.
- Subjects with a history of significant exposure, in the opinion of the investigator
and with prior discussion with the medical monitor, to medications known to produce
optic or peripheral neuropathy.
- Subjects with an active communicable disease (i.e., tuberculosis assessed as
currently communicable) and subjects on active treatment for tuberculosis or other
mycobacterial disease that include drugs that have known potential to produce ocular
or neurologic toxicity.
- Subjects with severe liver disease or abnormal liver function test.
- Subjects in Control Group:
- Subjects must not currently be taking linezolid or have received it for more than 7
days at any time.
- Subjects with a known presence of optic or peripheral nerve damage due to another
illness, condition or medication.
- Subjects with a pre-existing or a diagnosis at the screening visit of an
ophthalmologic condition that would adversely affect the study testing protocol (e.g.
dense cataracts, macular degeneration, retinitis pigmentosa).
- Subjects who are currently receiving another medication, antibiotic or other, that
has known potential to produce ocular or neurologic toxicity or lactic acidosis.
- Subjects with a history of significant exposure, in the opinion of the investigator
and with prior discussion with the medical monitor, to medications known to produce
optic or peripheral neuropathy.
- Subjects with an active communicable disease (i.e., tuberculosis assessed as
currently communicable) and subjects on active treatment for tuberculosis or other
mycobacterial disease that include drugs that have known potential to produce ocular
or neurologic toxicity. |
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| Study is available at: |
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Pfizer Investigational Site
Philadelphia, PA 19140
United States
Primary Contact:
Pfizer CT.gov Call Center
Phone: 1-800-718-1021 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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