View Clinical Trial (Medical Research Study)
A Phase 2b Trial of EPB-348 for the Treatment of Herpes Zoster - NCT00831103-77030(Clinical Trial 265996)
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| City: |
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Houston |
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State:
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TX |
| Zip Code: |
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77030 |
| Conditions: |
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Herpes Zoster - Antiviral Agents - Anti-Infective Agents |
| Purpose: |
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The purpose of this study is to determine the pharmacokinetics and dosage of EPB-348 that
best balances safety and efficacy among adult immunocompetent patients with an acute episode
of herpes zoster.
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| Study summary: |
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In cells infected with varicella-zoster virus, there is evidence to suggest that EPB-348
could offer clinically important advantages in the treatment of acute herpes zoster over
currently available therapies due to rapid absorption and conversion to the active moiety as
well as a longer intra-cellular half-life in infected cells. Clinically, these
characteristics could translate into once-daily dosing versus thrice-daily dosing as seen
with current therapy, leading to a higher rate of compliance and quality-of-life, especially
among elderly patients. The objective of EPB348-0201 is to determine the pharmacokinetics
and dosage of EPB-348 that best balances safety and efficacy among adult immunocompetent
patients with an acute episode of herpes zoster. This multi-center study will randomly
assign patients to either EPB-348 1000 mg once daily or EPB-348 2000 mg once daily or
valacyclovir 1000 mg three times daily. |
| Criteria: |
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Inclusion Criteria:
- Male and female adults at least 18 years of age
- Patients with signs and symptoms consistent with acute herpes zoster disease, namely,
a dermatomal vesicular rash which may be preceded by pain and parasthesias in the
days before vesicular eruption
- Herpes Zoster associated rash present for ≤ 72 hours
- Patients who are deemed to be immunocompetent based on history and physical exam
Exclusion Criteria:
- Females who are pregnant or nursing
- History or clinical manifestations of significant metabolic, hematological,
pulmonary, ischemic, or unstable heart disease, gastrointestinal, neurological,
psychiatric, renal, urological, endocrine, opthalmologic, or immune mediated disease
including HIV or HBsAg positivity
- Chronic genital herpes
- Patients who received cytotoxic or immunosuppressive drug therapy within 3 months
prior to study participation
- Previous vaccinations against Herpes Zoster
- Patients with > 50% of vesicles crusted at screen
- Patients who received topical or systemic antiviral medications or immunomodulatory
agents for herpes zoster viral infections or capsaicin within 4 weeks of study
participation
- Patients with a history of congenital, acquired, or corticosteroid induced
immunodeficiency, including malignancy, significantly impaired renal function
(creatinine clearance < 50 cc/min), and impaired hepatic function (ALT or AST levels
> 3 times the upper limit of normal)
- QTc > 500msec
- Patients with a history of intolerance or hypersensitivity to acyclovir, penciclovir,
valacyclovir, or famciclovir
- Patients with gastrointestinal dysfunction that might interfere with drug absorption
- Patients, considered by the investigator, for any reason, to be an unsuitable
candidate for receiving the study drug |
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| Study is available at: |
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Center for Clinical Studies-Medical Center
Houston, TX 77030
United States
Primary Contact:
Cruz Leonida
Email: lcruz@cctexas.com
Phone: 281-335-4605
Secondary Contact:
Liz Mead, BSc
Email: emead@encorium.com
Phone: 610-989-4225 |
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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 22, 2011 |
Modifications to
this listing: |
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