Herpes ZosterPhase 3NCT01327144
Efficacy of Oral Famciclovir Versus Aciclovir Treatment in Patients With Herpes Zoster
A Phase 3 study testing Famciclovir and Aciclovir in people with Herpes Zoster, run by EMS at 5 sites in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Famciclovir and Aciclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 5 sitesBrazil
- Study dates
- Jun 2012to Jul 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must be able to understand the study procedures, agree to participate and give written consent.
- Patients with clinical diagnosis of Herpes Zoster;
- Score higher than 4 for at least for 2 symptoms of Herpes Zoster;
- Negative pregnant urine test
Who cannot join
- Pregnancy or risk of pregnancy.
- Lactation
- Any pathology or past medical condition that can interfere with this protocol.
- Non-steroidal anti-inflammatory drug , hormonal anti-inflammatory or immunosuppressive drugs (in the last 30 days and during the study);
- Patients with immunodeficiency and/or immunosuppressive disease;
- Hypersensitivity to components of the formula;
- Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Brazil5 sites
Loema
Campinas, São Paulo, 13010001
Allergisa
Campinas, São Paulo
CECIP Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo
Centro de Medicina Reprodutiva Dr Carlos Isaia Filho
Porto Alegre, Rio Grande do Sul
Afip - Associacao Fundo de Incentivo A Pesquisa
São Paulo, São Paulo
About this study
Official title: A Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Famciclovir 500 mg Comparing To Aciclovir 400mg in Patients With Herpes Zoster
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.
Read the detailed description
Study Design
- single blind study, prospective, parallel group, intent to treat trial
- Experiment duration: 7 days
- 2 visits (days 0, and 7)
- Reduction of symptoms
- Adverse events evaluation
- Conditions
- Herpes Zoster
- Being tested
- Famciclovir, Aciclovir
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamciclovirDrug
Famciclovir 500 mg- 1 tablet each 12 hours for 7 days
AciclovirDrug
Aciclovir 400 mg- 02 tablets each 4 hours for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Famciclovir 500mg | Experimental | 1 tablet each 8 hours for 7 days Receives: Drug: Famciclovir |
| Aciclovir 400mg | Active comparator | 2 tablets of Aciclovir 400 mg each 4 hours for 7 days Receives: Drug: Aciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 7
Secondary outcomes (1)
Safety will be evaluated by the adverse events occurrences
Adverse events will be collected and followed in order to evaluate safety and tolerability
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startJun 2012
- Primary completionMay 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joyce Silva, MD, Study director, EMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327144
- Sponsor's protocol ID
- F500EMS1010
- Status last verified
- Apr 2019
- First submitted
- 30 Mar 2011
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29746903
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Famciclovir 500 mg Comparing To Aciclovir 400mg in Patients With Herpes Zoster
- ClinicalTrials.gov ID
- NCT01327144
- Acronym / sponsor ID
- F500EMS1010
- Conditions
- Herpes Zoster
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Jun 2012 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 1 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design
- single blind study, prospective, parallel group, intent to treat trial
- Experiment duration: 7 days
- 2 visits (days 0, and 7)
- Reduction of symptoms
- Adverse events evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Famciclovir 500mg | Experimental | Drug: Famciclovir1 tablet each 8 hours for 7 days |
| Aciclovir 400mg | Active comparator | Drug: Aciclovir2 tablets of Aciclovir 400 mg each 4 hours for 7 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients must be able to understand the study procedures, agree to participate and give written consent.
- Patients with clinical diagnosis of Herpes Zoster;
- Score higher than 4 for at least for 2 symptoms of Herpes Zoster;
- Negative pregnant urine test
Key exclusion criteria (7 listed)
- Pregnancy or risk of pregnancy.
- Lactation
- Any pathology or past medical condition that can interfere with this protocol.
- Non-steroidal anti-inflammatory drug , hormonal anti-inflammatory or immunosuppressive drugs (in the last 30 days and during the study);
- Patients with immunodeficiency and/or immunosuppressive disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FamciclovirFamciclovir 500 mg- 1 tablet each 12 hours for 7 days | Drug | Famciclovir 500mg |
| AciclovirAciclovir 400 mg- 02 tablets each 4 hours for 7 days | Drug | Aciclovir 400mg |
Primary outcome
For efficacy evaluation, a visual analogue scale (VAS) will be used to detect the improvement of symptoms
Time frame: day 7
Symptoms evaluated: pain, injury, loss of sensation, burning and itching
1 secondary outcome
Safety will be evaluated by the adverse events occurrences
Time frame: day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Results publication: PubMed 29746903Pott 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce Silva, MD study director
EMS
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Famciclovir and Aciclovir in people with Herpes Zoster, run by EMS at 5 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For efficacy evaluation, a visual analogue scale (VAS) will be used to detect the improvement of symptoms (time frame: day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01327144, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.