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Herpes Zoster is an infection that affects part of the nervous system caused by Varicella Zoster Virus. Herpes Zoster manifests as vesicular eruption in the dermatome, often associated with significant pain.
There are effective oral prescription antiviral medicines available to reduce the discomfort of symptoms as famciclovir and aciclovir.
This is a phase III, multicenter, randomized, parallel-group study to compare the efficacy and safety of treatment with Famciclovir (500 mg) comparing to Aciclovir (400 mg) in patients with Herpes Zoster.
Study Design
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Famciclovir 500mg | Experimental | 1 tablet each 8 hours for 7 days |
|
| Aciclovir 400mg | Active Comparator | 2 tablets of Aciclovir 400 mg each 4 hours for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famciclovir | Drug | Famciclovir 500 mg- 1 tablet each 12 hours for 7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| For efficacy evaluation, a visual analogue scale (VAS) will be used to detect the improvement of symptoms | Symptoms evaluated: pain, injury, loss of sensation, burning and itching | day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety will be evaluated by the adverse events occurrences | Adverse events will be collected and followed in order to evaluate safety and tolerability | day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joyce Silva, MD | EMS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Medicina Reprodutiva Dr Carlos Isaia Filho | Porto Alegre | Rio Grande do Sul | Brazil | |||
| Loema |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29746903 | Result | Pott Junior H, de Oliveira MFB, Gambero S, Amazonas RB. Randomized clinical trial of famciclovir or acyclovir for the treatment of herpes zoster in adults. Int J Infect Dis. 2018 Jul;72:11-15. doi: 10.1016/j.ijid.2018.04.4324. Epub 2018 May 7. |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D000077595 | Famciclovir |
| D000212 | Acyclovir |
| ID | Term |
|---|---|
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Aciclovir |
| Drug |
Aciclovir 400 mg- 02 tablets each 4 hours for 7 days |
|
| Campinas |
| São Paulo |
| 13010001 |
| Brazil |
| Allergisa | Campinas | São Paulo | Brazil |
| CECIP Centro de Estudos Clínicos do Interior Paulista | Jaú | São Paulo | Brazil |
| Afip - Associacao Fundo de Incentivo A Pesquisa | São Paulo | São Paulo | Brazil |
| D007239 | Infections |
| D006571 |
| Heterocyclic Compounds |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |