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This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Famciclovir 1000 mg; twice a day for one day. |
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| 2 | Placebo Comparator | Placebo; twice a day for one day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famciclovir | Drug | oral; two 500 mg tablets twice a day; single day treatment |
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| 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, defined as the time from the first dose of study medication to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of lesions; erythema may be present). | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period | 21 days | |
| Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions | Kaplan-Meier estimation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dalu Mohammed, Dr | Clayton Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Clinical Research | Burbank | California | 91505 | United States | ||
| Alia Clinical Research, INC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20070143 | Derived | Leone P, Abudalu M, Mitha E, Gani M, Zhou W, Hamed K. One-day famciclovir vs. placebo in patient-initiated episodic treatment of recurrent genital herpes in immunocompetent Black patients. Curr Med Res Opin. 2010 Mar;26(3):653-61. doi: 10.1185/03007990903554471. |
| Label | URL |
|---|---|
| Click here for more information on this study | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Famciclovir 1000 mg | Famciclovir 1000 mg; twice a day for one day for treatment. |
| FG001 | Placebo Comparator | Placebo twice a day for one day for treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | oral; two tablets twice a day; single day treatment |
|
| 21 days |
| Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | Median time to resolution of symptoms: all symptoms, pain, burning, itching, tingling and tenderness associated with recurrent genital herpes estimated using Kaplan-Meier method. | 72 hour after initiation of study medication up to 21 days |
| Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period | Number of participants with a second recurrence of genital herpes in the follow-up period. | 6 months |
| Time to Second Recurrence of Genital Herpes | Kaplan Meier estimated time in days to second recurrent from treatment initiation and from the date of healing of aborted lesions. | 6 months |
| The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | The number of participants with clinically noted shifts in Hematology tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful. | Baseline, Day 2 |
| The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | The number of participants with clinically noted shifts in Clinical Chemistry tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful. SGPT(ALT)= Serum Glutamic Pyruvate Transaminase (Alanine Aminotransferase) and SGOT(AST)= Serum Glutamic Oxalacetic Transaminase (Aspartate Aminotransferase) | Baseline, Day 2 |
| Huntington Park |
| California |
| 90255 |
| United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| The Conant Foundation Quest Diagnostics | San Francisco | California | 94114 | United States |
| Medical Research Centers of South Florida, Inc. | Hollywood | Florida | 33021 | United States |
| First Coast Primary Care Minority Physicians Research Alliance | Jacksonville | Florida | 32208 | United States |
| AppleMed Research Inc. | Miami | Florida | 33155 | United States |
| International Research Associates, LLC | Miami | Florida | 33156 | United States |
| Segal Institute for Clinical Research Heathcare Clinical Data, Inc | North Miami | Florida | 33161 | United States |
| Perimeter Institute for Clinical Research Inc. ("PICR") | Atlanta | Georgia | 30338 | United States |
| Medical College of Georgia Hospital and Clinics | Augusta | Georgia | 30912 | United States |
| Soapstone Center for Clinical Research | Decatur | Georgia | 30034 | United States |
| Mount Vernon Clinical Research, LLC | Sandy Springs | Georgia | 30328 | United States |
| Clinical Trials Management LLC | Covington | Louisiana | 70433 | United States |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Omni Fertility and Laser Institute | Shreveport | Louisiana | 71118 | United States |
| International Research Center | Towson | Maryland | 21286 | United States |
| Miray Medical Center | Brockton | Massachusetts | 02301 | United States |
| Pearl Medical Group, PLLC | Southfield | Michigan | 48075 | United States |
| Dr. Mohammed | St Louis | Missouri | 63117 | United States |
| Nevada Alliance Against Diabetes | Las Vegas | Nevada | 89101 | United States |
| Metrolina Internal Medicine Internal Medicine Research | Charlotte | North Carolina | 28204 | United States |
| Peters Medical Research | High Point | North Carolina | 27262 | United States |
| UNC Clinical Research | Raleigh | North Carolina | 27607 | United States |
| Hawthorne Medical Research, Inc. | Winston-Salem | North Carolina | 27103 | United States |
| Planned Parenthood of Arkansas and Eastern Oklahoma | Tulsa | Oklahoma | 74105 | United States |
| The Clinical Trial Center, LLC | Jenkintown | Pennsylvania | 19046 | United States |
| Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| Women's Care Center, PLC: Research Memphis Associates | Memphis | Tennessee | 38119 | United States |
| Private Practice | Fort Worth | Texas | 76110 | United States |
| R/D Clinical Research, Inc | Houston | Texas | 77074 | United States |
| Sun Research Institute | San Antonio | Texas | 78205 | United States |
| Millennium Clinical Trials, LLC | Arlington | Virginia | 22203 | United States |
| Josha Research | Bloemfontein | South Africa |
| Prime Cure Medicentre | Durban | South Africa |
| Umkomaas Clinical Research Site | eMkhomazi | South Africa |
| Drs. Essack and Mitha | Johannesburg | South Africa |
| Medunsa Clinical Research Unit (MeCRU) | Medunsa | South Africa |
| Bertoni Mercy Clinic | Mmakau Village GA Rankuwa | South Africa |
| Global Clinical Trials | Port Elizabeth | South Africa |
| Eastmed Clinical Trial Centre/Eastmed Medical Centre | Pretoria | South Africa |
| Setshaba Research Centre | Shoshanguve | South Africa |
| Drs. AE and QE Bhorat | Soweto | South Africa |
| Randomized and Took Study Drug |
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| Intent to Treat Population |
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| Participants Completing First Recurrence |
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| Modified Intent to Treat Population |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Famciclovir 1000 mg | Famciclovir 1000 mg; twice a day for one day for treatment. |
| BG001 | Placebo Comparator | Placebo twice a day for one day for treatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Intent to Treat population consists of all randomized participants who initiated treatment with the study drug with the intention of treating genital herpes recurrences | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Intent to Treat population consists of all randomized patients who initiated treatment with the study drug with the intention of treating genital herpes recurrences | Count of Participants | Participants |
| |||||||||||||||
| Number of Years: recurrent genital herpes | Number of years the participant has experienced recurrent genital herpes. Intent to Treat population consists of all randomized participants who initiated treatment with the study drug with the intention of treating genital herpes recurrences | Mean | Standard Deviation | Years |
| ||||||||||||||
| Genital herpes recurrence in last 12 months | Number of genital herpes recurrences during the last 12 months or in the 12 months immediately preceding suppressive treatment. Intent to Treat population consists of all randomized participants who initiated treatment with the study drug with the intention of treating genital herpes recurrences | Mean | Standard Deviation | Genital herpes recurrences |
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| 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, defined as the time from the first dose of study medication to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of lesions; erythema may be present). | Modified Intent to Treat Population (mITT) that includes all Intent to Treat participants with non-aborted genital herpes lesions during the treatment period. | Posted | Median | Inter-Quartile Range | Days | 21 days |
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| Secondary | Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period | Intent-to-Treat (ITT). All randomized participants who initiated treatment (i.e. received any dose of the study drug) with the intention of treating genital herpes recurrences. | Posted | Number | Percentage of Participants | 21 days |
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| Secondary | Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions | Kaplan-Meier estimation. | ITT participants who discontinued from the study before healing of non aborted lesions was confirmed and participants 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 as having non aborted lesions in this analysis. | Posted | Median | Inter-Quartile Range | Days | 21 days |
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| Secondary | Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | Median time to resolution of symptoms: all symptoms, pain, burning, itching, tingling and tenderness associated with recurrent genital herpes estimated using Kaplan-Meier method. | Intent to Treat Population. If a participant never had a symptom prior to the last valid diary entry for the first recurrence, then the time to resolution of the symptom was set to missing and the participant was not included in the analysis. | Posted | Median | Inter-Quartile Range | Days | 72 hour after initiation of study medication up to 21 days |
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| Secondary | Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period | Number of participants with a second recurrence of genital herpes in the follow-up period. | Intent to Treat Population: participants who completed the first recurrence. | Posted | Number | Participants | 6 months |
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| Secondary | Time to Second Recurrence of Genital Herpes | Kaplan Meier estimated time in days to second recurrent from treatment initiation and from the date of healing of aborted lesions. | Intent to Treat Population: participants who completed the first recurrence. | Posted | Median | Inter-Quartile Range | Days | 6 months |
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| Secondary | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | The number of participants with clinically noted shifts in Hematology tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful. | 304 Participants = 206 participants in the Famciclovir Group + 98 participants in the Placebo Group. Individual n values in each of the categories is the number of participants in the group with normal baseline values and at least one non-missing post baseline measurement. | Posted | Number | Participants | Baseline, Day 2 |
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| Secondary | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | The number of participants with clinically noted shifts in Clinical Chemistry tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful. SGPT(ALT)= Serum Glutamic Pyruvate Transaminase (Alanine Aminotransferase) and SGOT(AST)= Serum Glutamic Oxalacetic Transaminase (Aspartate Aminotransferase) | 304 Participants = 206 participants in the Famciclovir Group + 98 participants in the Placebo Group. Individual n values in each of the categories is the number of participants in the group with normal baseline values and at least one non-missing post baseline measurement. | Posted | Number | Participants | Baseline, Day 2 |
|
21 days
AEs presented in this section are the AEs greater than 1% that occured in the treatment period. SAEs presented in this section are these that were reported either during the treatment or follow-up period (one SAE was reported during the follow-up period).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Famciclovir 1000 mg | Famciclovir 1000 mg; twice a day for one day for treatment. | 2 | 206 | 26 | 206 | ||
| EG001 | Placebo Comparator | Placebo twice a day for one day for treatment. | 1 | 98 | 11 | 98 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Palpitations | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Radius Fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Blood Pressure increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Adnexa uteri pain | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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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 |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006561 | Herpes Simplex |
| 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 |
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| ID | Term |
|---|---|
| D000077595 | Famciclovir |
| ID | Term |
|---|---|
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
|
| No |
| Superiority or Other |
| Participants who discontinued from the study before healing of non-aborted lesions was confirmed and participants 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 censored at the time of the last clinical lesion observation. | Kaplan-Meier & Cox Regression | 0.9372 | Cox Proportional Hazard | 1.01 | 2-Sided | 95 | 0.74 | 1.39 | Hazard ratio in time to healing=hazard rate of Famciclovir/hazard rate of Placebo. Based on Cox proportional hazards model with treatment, pooled center and gender as explanatory variables. | No | Superiority or Other |
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| Participants |
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| Units | Counts |
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| Participants |
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