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View Clinical Trial (Medical Research Study)
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A Study of FV-100 Versus Valacyclovir in Patients With Herpes Zoster - NCT00900783-22304 (Clinical Trial 440089)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy440089.aspx
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| City: |
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Alexandria |
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State:
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VA |
| Zip Code: |
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22304 |
| Conditions: |
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Herpes Zoster - Shingles |
| Purpose: |
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The purpose of this study is to compare the safety and efficacy of two doses of FV-100 to
valacyclovir in patients with herpes zoster, or shingles. FV-100 has shown to be very
potent in cells infected with varicella zoster virus, the virus that causes shingles. The
study objectives include:
- Compare the safety of FV-100 to valacyclovir
- Compare the effect of FV-100, as compared to valacyclovir, on shingles pain
- Compare the effect of FV-100, as compared to valacyclovir, on shingles lesions
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Men and women ≥ 50 years of age
- Patients with a clinical diagnosis of HZ as evidenced by a unilateral dermatomal rash
- Patients with zoster-related pain (ZBPI worst pain score > 0)
- Patients able to be enrolled into the study ≤ 72 hours from appearance of rash (i.e.,
lesions or vesicles)
- Patients providing written informed consent
- Patients who are able to complete all study visits per protocol
- Men and premenopausal women must agree to practice a barrier method of birth control
plus the use of a spermicide for one month after the last dose of study drug (oral
contraceptives are not permitted)
Exclusion Criteria:
- Women who are pregnant or lactating
- Patients with multidermatomal or disseminated HZ (i.e., > 20 vesicles beyond the
dermatomes adjacent to the primarily involved dermatome)
- Patients with HZ ophthalmicus, defined as cutaneous lesions in the dermatome
associated with the ophthalmic division of the trigeminal nerve
- Patients with history of impaired renal function, (e.g., calculated creatinine
clearance <50 mL/min/1.73 m2)
- Patients taking narcotic analgesic routinely for a chronic pain condition
- Patients taking tricyclic antidepressants
- Patients who have received systemic antivirals with activity against VZV within the
past 30 days, or a topical antiviral to treat their current HZ
- Patients who are immunosuppressed from:
- disease (e.g., malignancy [present or remission < 5 years], HIV)
- corticosteroid use (except intermittent or topical/inhaled beclomethasone
dipropionate or equivalent < 800 mcg/day), or
- other immunosuppressive/cytotoxic therapy (cancer chemotherapy or organ
transplantation)
- Patients with gastrointestinal dysfunction that could interfere with drug absorption
- Patients with any other condition (e.g., extensive psoriasis, chronic pain syndrome,
cognitive impairment) that, in the opinion of the site investigator, might interfere
with the evaluations required by the study
- Patients who are not ambulatory (bed-ridden or homebound); hospitalized patients may
be enrolled if they are ambulatory and able to complete the study requirements
- Patients with history of allergy to valacyclovir hydrochloride
- Patients unlikely to adhere to protocol follow-up
- Patients taking CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole,
telithromycin) or strong CYP3A4 inducers (e.g., rifampin, carbamazepine) |
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| Study is available at: |
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Alexandria Clinical Research, LLC
Alexandria, VA 22304
United States
Primary Contact:
Eric Wenzel, BS
Email: ewenzel@inhibitex.com
Phone: 678-746-1129 |
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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 16, 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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