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This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Famciclovir | Experimental | Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart. |
|
| Valacyclovir | Active Comparator | Patients received Valacyclovir 500 mg capsule twice a day approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famciclovir | Drug | Famciclovir 500 mg tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions | 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. | 72 hours after initiation of study medication up to Day 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Aborted Genital Herpes Lesions | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Additional protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19192993 | Derived | Bodsworth N, Fife K, Koltun W, Tyring S, Abudalu M, Prichard M, Hamed K. Single-day famciclovir for the treatment of genital herpes: follow-up results of time to next recurrence and assessment of antiviral resistance. Curr Med Res Opin. 2009 Feb;25(2):483-7. doi: 10.1185/03007990802664678. |
| Label | URL |
|---|---|
| eRecruitment | View source |
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A total of 1179 patients were randomized in the study and followed to their first genital herpes recurrence. A total of 423 patients did not experience a recurrence within 4 months of randomization therefore, no treatment was initiated and study drug was not taken. A total of 756 patients were randomized and took study drug (safety population).
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| ID | Title | Description |
|---|---|---|
| FG000 | Famciclovir | Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Valacyclovir | Drug | Valacyclovir 500 mg capsule |
|
|
| Placebo matching famciclovir | Drug | Famciclovir placebo, matching in size, color and forms of famciclovir tablet. |
|
| Placebo matching valacyclovir | Drug | Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule. |
|
| 72 hours after initiation of study medication up to Day 20 |
| Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions | 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. | 72 hours after initiation of study medication up to Day 20 |
| Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | 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. | 72 hours after initiation of study medication up to Day 20 |
| Number of Patients With a Second 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. | Up to 6 months after investigator assessed healing of first recurrence of genital herpes |
| Time to a Second 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:
| Up to 6 months after investigator assessed healing of first recurrence of genital herpes |
| Chandler |
| Arizona |
| 85225 |
| United States |
| Women's Health Research | Phoenix | Arizona | 85015 | United States |
| Quality of Life Medical & Research Center, LLC | Tucson | Arizona | 85712 | United States |
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | United States |
| NEA Women's Clinic | Jonesboro | Arkansas | 72401 | United States |
| The Woman's Clinic | Little Rock | Arkansas | 72205 | United States |
| Providence Clinical Research | Burbank | California | 91505 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Sacramento Research Medical Group | Sacramento | California | 95825 | United States |
| North California Research Corp. | Sacramento | California | 95831 | United States |
| Medical Center for Clinical Research | San Diego | California | 92108 | United States |
| Conant Research | San Francisco | California | 94114 | United States |
| Barbara Davis Center | Denver | Colorado | 80262 | United States |
| Cohen & Womack, P.C. | Lakewood | Colorado | 80228 | United States |
| Visions Clinical Research | Boynton Beach | Florida | 33437 | United States |
| Women's Medical Research Group, LLC | Clearwater | Florida | 33759 | United States |
| International Research Association LLC | Miami | Florida | 33156 | United States |
| Orlando Clinical Research Ctr. | Orlando | Florida | 32809 | United States |
| Avancia Research | Pembroke Pines | Florida | 33024 | United States |
| University Clinical Research, Inc. | Pembroke Pines | Florida | 33024 | United States |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | United States |
| Mount Vernon Clinical Research | Atlanta | Georgia | 30328 | United States |
| Medisphere Medical Research Center, LLC. | Evansville | Indiana | 47714 | United States |
| Indiana University Infectious Disease Research Group | Indianapolis | Indiana | 46202 | United States |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | United States |
| Common Wealth Biomedical Research | Madisonville | Kentucky | 42431 | United States |
| SNBL Clinical Pharmacology Center | Baltimore | Maryland | 21201 | United States |
| Future Care Studies | Springfield | Massachusetts | 01107 | United States |
| Clayton Research Institute | St Louis | Missouri | 63117 | United States |
| Deaconess Billings Clinic Research Center | Billings | Montana | 59101 | United States |
| Heartland Clinical Research, Inc. | Omaha | Nebraska | 68134 | United States |
| UNC Clinical Research. | Raleigh | North Carolina | 27607 | United States |
| Hawthorne Medical Research, Inc. | Winston-Salem | North Carolina | 27103 | United States |
| Providence Health Partners-Center for Clinical Research | Dayton | Ohio | 45439 | United States |
| Lynne Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Westover Heights Clinic | Portland | Oregon | 97210 | United States |
| Paddington Testing Co. Inc | Philadelphia | Pennsylvania | 19103 | United States |
| Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| S. Carolina Clinical Research Center | Columbia | South Carolina | 29201 | United States |
| Research Inc. | Florence | South Carolina | 29501 | United States |
| Palmetto Clinical Trial Services, LLC | Simpsonville | South Carolina | 29681 | United States |
| Benchmark Research | Austin | Texas | 78705 | United States |
| Renaissance Clinical Research and Hypertension Clinic | Dallas | Texas | 75235 | United States |
| Center for Clinical Studies (TX Medical Center) | Houston | Texas | 77030 | United States |
| Center for Clinical Studies | Houston | Texas | 77058 | United States |
| University of Utah-School of Medicine (Div. of Inf. Disease) | Salt Lake City | Utah | 84132 | United States |
| Salt Lake Women's Center/Physician's Research Options | Sandy City | Utah | 84070 | United States |
| Clinical Trials of Virginia, Inc. | Richmond | Virginia | 23225 | United States |
| University of Washington, Virology Research Clinic | Seattle | Washington | 98122 | United States |
| Liberty Research Center | Tacoma | Washington | 98405 | United States |
| Novartis Investigative Site | Darlinghurst | New South Wales | 2010 | Australia |
| Novartis Investigational Site | Edmonton | Alberta | T6G 2B6 | Canada |
| Novartis Investigational Site | Vancouver | British Columbia | V6Z 2C7 | Canada |
| Novartis Investigational Site | Winnipeg | Manitoba | R3E 0W3 | Canada |
| Novartis Investigational Site | Markham | Ontario | L3P 1A8 | Canada |
| Novartis Investigational Site | Ottawa | Ontario | K1S 0G8 | Canada |
| Novartis Investigational Site | Laval | Quebec | H7X 3S5 | Canada |
| Novartis Investigational Site | Montreal | Quebec | H2K 4L5 | Canada |
| Novartis Investigational Site | Montreal | Quebec | H3H IV4 | Canada |
| Novartis Investigational Site | Sainte-Foy | Quebec | G1V 4G2 | Canada |
| Novartis Investigational Site | Augsburg | D-86179 | Germany |
| Novartis Investigational Site | Berlin | Germany |
| Novartis Investigational Site | Freiburg im Breisgau | 79106 | Germany |
| Novartis Investigational Site | Rostock | D-18055 | Germany |
| Novartis Investigational Site | Wolfsburg | D-38440 | Germany |
| FG001 | Valacyclovir | Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir. |
| Received Study Drug (Safety Population) |
|
| Intent to Treat (ITT) Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Famciclovir | Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart. |
| BG001 | Valacyclovir | Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Demographic data is provided for the intent to treat (IIT) population, which 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. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions | 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. | 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. | Posted | Median | Inter-Quartile Range | days | 72 hours after initiation of study medication up to Day 20 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Aborted Genital Herpes Lesions | 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. | 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. | Posted | Number | Percentage of participants | 72 hours after initiation of study medication up to Day 20 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions | 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. | 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. | Posted | Median | Inter-Quartile Range | days | 72 hours after initiation of study medication up to Day 20 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | 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. | 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. | Posted | Median | Inter-Quartile Range | hours | 72 hours after initiation of study medication up to Day 20 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With a Second 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. | 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. | Posted | Number | participants | Up to 6 months after investigator assessed healing of first recurrence of genital herpes |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to a Second 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:
| ITT population. Patients with missing time-to-second recurrence were not included in the calculation of the median. | Posted | Median | Inter-Quartile Range | days | Up to 6 months after investigator assessed healing of first recurrence of genital herpes |
|
30 days post last dose of study medication
Safety Population
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Famciclovir | Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart. | 2 | 371 | 66 | 371 | ||
| EG001 | Valacyclovir | Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir. | 1 | 385 | 47 | 385 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial ischemia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Substance Abuse | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D006558 | Herpes Genitalis |
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077595 | Famciclovir |
| D000077483 | Valacyclovir |
| ID | Term |
|---|---|
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
Not provided
Not provided
| Male |
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| Units | Counts |
|---|---|
| Participants |
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