Trial · NCT00306787
Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes
NCT00306787, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2011-06-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes. Trials, record NCT00306787. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00306787
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes
- NCT number
- NCT00306787
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,179 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Genital Herpes
- Interventions
- Famciclovir, Valacyclovir, Placebo matching famciclovir, Placebo matching valacyclovir
- First posted
- 2006-03-24
- Last updated
- 2011-06-30
- Results first posted
- 2011-06-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions | 72 hours after initiation of study medication up to Day 20 | Time to healing of all non-aborted genital herpes lesions was defined as the time from the first dose of study drug taken no earlier than the recurrence of genital herpes to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of the lesions; erythema could have been present). Non-aborted lesions are lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing. The median time was estimated using Kaplan-Meier method by censoring missing values at the time of last clinical lesion observation. |
| Secondary | Percentage of Participants With Aborted Genital Herpes Lesions | 72 hours after initiation of study medication up to Day 20 | Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions. |
| Secondary | Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions | 72 hours after initiation of study medication up to Day 20 | Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions. The median time was estimated using Kaplan-Meier method. |
| Secondary | Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | 72 hours after initiation of study medication up to Day 20 | Kaplan-Meier estimated time in hours of the resolution of all symptoms (pain, burning, itching, tingling and tenderness) associated with recurrent genital herpes. Kaplan-Meier method is used to estimate the time to resolution of symptoms. |
| Secondary | Number of Patients With a Second Recurrence of Genital Herpes | Up to 6 months after investigator assessed healing of first recurrence of genital herpes | Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence. |
| Secondary | Time to a Second Recurrence of Genital Herpes | Up to 6 months after investigator assessed healing of first recurrence of genital herpes | Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence. Time to a second recurrence of genital herpes was calculated in 2 ways as follows: 1. From the date of treatment initiation no earlier than the recurrence of genital herpes to the date of onset for the second recurrence, or 2. From the date of healing of non-aborted lesions or confirmation of aborted lesions to the date of onset for the second recurrence. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions | 72 hours after initiation of study medication up to Day 20 | Modified Intent To Treat (mITT) population. The mITT population included all patients who initiated treatment with the study drug, with the intention of treating genital herpes recurrences who developed non-aborted genital herpes lesions during the treated recurrence except those with confirmed aborted lesions at the final clinical assessment. | days | MEDIAN |
| SECONDARY | Percentage of Participants With Aborted Genital Herpes Lesions | 72 hours after initiation of study medication up to Day 20 | ITT population. Patients who discontinued from the study before healing of non-aborted lesions was confirmed and patients who completed the study after 21 days since treatment initiation without non-aborted lesion stages and without a final assessment on aborted lesion status were assumed to have non-aborted lesions in this analysis. | Percentage of participants | NUMBER |
| SECONDARY | Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions | 72 hours after initiation of study medication up to Day 20 | ITT population. Median time was estimated by kaplan-Meier method by censoring the missing non-aborted times at last clinical observation. Patients with aborted lesions were assigned a time to healing of zero. | days | MEDIAN |
| SECONDARY | Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | 72 hours after initiation of study medication up to Day 20 | ITT population. If the resolution of any or all symptoms was not confirmed by a subsequent visit or diary entry, the time to resolution was censored at the time of the last diary entry. If a patient dropped out before any diary entries were created, the patient was assigned a censoring time of 0. n= number of patients with symptoms. | hours | MEDIAN |
| SECONDARY | Number of Patients With a Second Recurrence of Genital Herpes | Up to 6 months after investigator assessed healing of first recurrence of genital herpes | ITT population included all randomized patients who initiated treatment with (i.e. received any dose of) the study drug, with the intention of treating genital herpes recurrences. | participants | NUMBER |
| SECONDARY | Time to a Second Recurrence of Genital Herpes | Up to 6 months after investigator assessed healing of first recurrence of genital herpes | ITT population. Patients with missing time-to-second recurrence were not included in the calculation of the median. | days | MEDIAN |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions | Famciclovir | 4.25 | Inter-Quartile Range 3.06 to 5.78 | days | |
| Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions | Valacyclovir | 4.08 | Inter-Quartile Range 3.02 to 5.80 | days | |
| Percentage of Participants With Aborted Genital Herpes Lesions | Famciclovir | Aborted Lesions | 32.7 | Percentage of participants | |
| Percentage of Participants With Aborted Genital Herpes Lesions | Valacyclovir | Aborted Lesions | 33.6 | Percentage of participants | |
| Percentage of Participants With Aborted Genital Herpes Lesions | Famciclovir | Non-Aborted lesions | 67.3 | Percentage of participants | |
| Percentage of Participants With Aborted Genital Herpes Lesions | Valacyclovir | Non-Aborted lesions | 66.4 | Percentage of participants | |
| Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions | Famciclovir | 3.07 | Inter-Quartile Range 0.00 to 5.00 | days | |
| Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions | Valacyclovir | 3.01 | Inter-Quartile Range 0.00 to 4.88 | days | |
| Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | Famciclovir | Pain (n = 220, 228) | 18.0 | Inter-Quartile Range 0.0 to 52.7 | hours |
| Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | Valacyclovir | Pain (n = 220, 228) | 20.3 | Inter-Quartile Range 0.00 to 46.6 | hours |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Famciclovir | 579 | |
| Overall Study | STARTED | Valacyclovir | 600 | |
| Overall Study | Received Study Drug (Safety Population) | Famciclovir | 371 | |
| Overall Study | Received Study Drug (Safety Population) | Valacyclovir | 385 | |
| Overall Study | Intent to Treat (ITT) Population | Famciclovir | 370 | |
| Overall Study | Intent to Treat (ITT) Population | Valacyclovir | 381 | |
| Overall Study | COMPLETED | Famciclovir | 345 | |
| Overall Study | COMPLETED | Valacyclovir | 359 | |
| Overall Study | NOT COMPLETED | Famciclovir | 234 | |
| Overall Study | NOT COMPLETED | Valacyclovir | 241 |
Source ClinicalTrials.gov
Adverse events16
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 | 29 | 371 | |
| other | Headache | Nervous system disorders | Valacyclovir | 17 | 385 | |
| other | Nausea | Gastrointestinal disorders | Famciclovir | 23 | 371 | |
| other | Nausea | Gastrointestinal disorders | Valacyclovir | 18 | 385 | |
| other | Diarrhea | Gastrointestinal disorders | Famciclovir | 8 | 371 | |
| other | Diarrhea | Gastrointestinal disorders | Valacyclovir | 5 | 385 | |
| other | Vomiting | Gastrointestinal disorders | Famciclovir | 5 | 371 | |
| other | Vomiting | Gastrointestinal disorders | Valacyclovir | 3 | 385 | |
| other | Abdominal pain | Gastrointestinal disorders | Famciclovir | 1 | 371 | |
| other | Abdominal pain | Gastrointestinal disorders | Valacyclovir | 4 | 385 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Famciclovir | ||
| Total, all-cause mortality | Valacyclovir | ||
| Total, other adverse events | Famciclovir | 66 | 371 |
| Total, other adverse events | Valacyclovir | 47 | 385 |
| Total, serious adverse events | Famciclovir | 2 | 371 |
| Total, serious adverse events | Valacyclovir | 1 | 385 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19192993 | DERIVED |
Source PubMed
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 vs Valacyclovir: 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/NCT00306787
GET https://conductscience.org/api/trials/v1/NCT00306787/results?page=2