Trial · NCT01281007
Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes
NCT01281007, Phase 3, Completed, EMS; results first posted 2015-07-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes. Trials, record NCT01281007. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01281007
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes
- NCT number
- NCT01281007
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 150 participants, actual
- Lead sponsor
- EMS
- Conditions
- GENITAL HERPES
- Interventions
- Famciclovir, Aciclovir
- First posted
- 2011-01-21
- Last updated
- 2021-04-21
- Results first posted
- 2015-07-07
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation | Day 5 | Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin. |
| Secondary | Safety Will be Evaluated by the Adverse Events Occurence | Day 5 | Adverse events will be collected and followed in order to evaluate safety and tolerability |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation | Day 5 | subjects | NUMBER | |
| SECONDARY | Safety Will be Evaluated by the Adverse Events Occurence | Day 5 |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation | Famciclovir 125 mg | 73 | subjects | ||
| Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation | Aciclovir 200 mg | 52 | subjects |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Famciclovir 125 mg | 75 | |
| Overall Study | STARTED | Aciclovir 200 mg | 75 | |
| Overall Study | COMPLETED | Famciclovir 125 mg | 71 | |
| Overall Study | COMPLETED | Aciclovir 200 mg | 67 | |
| Overall Study | NOT COMPLETED | Famciclovir 125 mg | 4 | |
| Overall Study | NOT COMPLETED | Aciclovir 200 mg | 8 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Famciclovir 125 mg | 10 | 75 | 10 |
| other | Headache | Nervous system disorders | Aciclovir 200 mg | 12 | 75 | 12 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Famciclovir 125 mg | ||
| Total, all-cause mortality | Aciclovir 200 mg | ||
| Total, other adverse events | Famciclovir 125 mg | 10 | 75 |
| Total, other adverse events | Aciclovir 200 mg | 12 | 75 |
| Total, serious adverse events | Famciclovir 125 mg | 0 | 75 |
| Total, serious adverse events | Aciclovir 200 mg | 0 | 75 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Famciclovir 125 mg vs Aciclovir 200 mg: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01281007
GET https://conductscience.org/api/trials/v1/NCT01281007/registered