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Eligible subjects will be randomized to receive VALTREX® tablet 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days between treatment periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: VALTREX 1 g once daily, Placebo | Experimental | VALTREX 1 g once daily, Placebo |
|
| Sequence 2: Placebo, VALTREX 1 g once daily | Experimental | Placebo, VALTREX 1 g once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valaciclovir | Drug | Valtrex 1g once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Days of Subclinical Shedding as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for HSV-2 | Percent of subclinical days with HSV-2 shedding was defined for each participant as the percent of subclinical days with PCR data for which HSV-2 shedding was detected by a positive PCR result, that is, the number of subclinical days with HSV-2 PCR shedding divided by total number of subclinical days with PCR data, multiplied by 100. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or subclinical (no genital lesions). Genital/anal-rectal swabs was collected daily during each entire 60-day treatment period of each period and the washout period. | Up to Day 60 of each treatment period (up to 160 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Days of Total HSV-2 Shedding | The percent of days with total (clinical and subclinical) HSV-2 shedding was defined as the percent of all days with PCR data for which HSV-2 shedding was detected. Mean percent of days with total HSV-2 shedding was the statistic used to summarize this endpoint for each treatment group. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions). The total shedding rate was defined for each participant as the percentage of all days (clinical and subclinical) on treatment during which shedding was detected by PCR. Genital/anal-rectal swabs was collected daily during each entire 60-day treatment period of each period and the washout period. |
Not provided
Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Carmichael | California | 95608 | United States | ||
| GSK Investigational Site |
Not provided
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| VLX103596 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Not provided
Not provided
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Eligible male or female immunocompetent participants in general good health were enrolled. Additionally, participants must be Herpes Simplex Virus Type 2 (HSV-2) seropositive at screening. VALTREX (valacyclovir hydrochloride) is registered trademark of GlaxoSmithKline.
From March-2005 to January-2006, 73 participants from 13 centers in the United States were randomized into the study (36 in VALTREX™-Placebo, and 37 in Placebo-VALTEX treatment sequence). One participant in each treatment sequence did not receive study medication and intent-to-treat exposed (ITTE) population was comprised of 71 participants.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: VALTREX 1 g Once Daily, Placebo | Participants randomized to this sequence received VALTREX 1 gram (g) once daily for 60 days, to be taken as two 500 milligram (mg) caplets in Period 1 followed by matching placebo for 60 days in Period 2 with 7 days of washout period between 2 periods. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: Treatment Period 1 (60 Days) |
|
Not provided
Not provided
Not provided
Not provided
Not provided
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| Placebo | Drug | placebo |
|
| Up to Day 60 of each treatment period (up to 160 days) |
| Number of Participants With no Shedding | The number of participants with no shedding was defined as the number of participants with no HSV-2 shedding detected by PCR divided by the total number of participants with PCR data. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions). | Up to Day 60 of each treatment period (up to 160 days) |
| Mean Log HSV-2 DNA Copy Number Per Day on Days With Subclinical Shedding | The subclinical shedding rate was defined for each participant as the total number of subclinical days on treatment during which shedding was detected by PCR. Average log HSV-2 DNA copy number per day on days with subclinical shedding was defined as the daily maximum HSV-2 DNA copy number was log transformed and averaged over all subclinical shedding days. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions). | Up to Day 60 of each treatment period (up to 160 days) |
| Mean Log HSV-2 DNA Copy Number Per Day on Days With Total Shedding | The total shedding rate was defined for each participant as the total number of all days (clinical and subclinical) on treatment during which shedding was detected by PCR. Average log HSV-2 DNA copy number per day on days with total shedding (clinical and subclinical) was defined as the daily maximum HSV-2 DNA copy number was log transformed and averaged over all shedding days. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions). | Up to Day 60 of each treatment period (up to 160 days) |
| Percent Overall Study Population Who Have Recognized Clinical Signs/Symptoms of Genital Herpes Infection During the Study | Participants who have recognized clinical signs/symptoms of genital herpes infection during the study. Participants were educated on recognizing signs and symptoms of genital herpes infection at the screening/randomization visit. Genital examinations was conducted at the randomization and genital herpes outbreak visits. | Up to Day 60 of each treatment period (up to 160 days) |
| Davis |
| California |
| 95616 |
| United States |
| GSK Investigational Site | Riverside | California | 92506 | United States |
| GSK Investigational Site | Sacramento | California | 92585 | United States |
| GSK Investigational Site | Fort Wayne | Indiana | 46804 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46202 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02115 | United States |
| GSK Investigational Site | New York | New York | 10011 | United States |
| GSK Investigational Site | New York | New York | 10029 | United States |
| GSK Investigational Site | Stony Brook | New York | 11794 | United States |
| GSK Investigational Site | The Bronx | New York | 10461 | United States |
| GSK Investigational Site | Chapel Hill | North Carolina | 27599 | United States |
| GSK Investigational Site | Tulsa | Oklahoma | 74104 | United States |
| GSK Investigational Site | Portland | Oregon | 97210 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84132 | United States |
| GSK Investigational Site | Seattle | Washington | 98104 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| VLX103596 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| VLX103596 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| VLX103596 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| VLX103596 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| VLX103596 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| VLX103596 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | Sequence 2: Placebo, VALTREX 1 g Once Daily | Participants randomized to this sequence received matching placebo for 60 days, to be taken as two 500 mg caplets in Period 1 followed by VALTREX 1 g once daily for 60 days in Period 2 with 7 days of washout period between 2 periods. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2: Washout Period (7 Days) |
|
| Period 1: Treatment Period 2 (60 Days) |
|
|
The ITTE population was defined as consisting of all participants who received at least one dose of investigational product and at least one safety and/or efficacy evaluation.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1: VALTREX 1 g Once Daily, Placebo | Participants randomized to this sequence received VALTREX 1 g once daily for 60 days, to be taken as two 500 mg caplets in Period 1 followed by matching placebo for 60 days in Period 2 with 7 days of washout period between 2 periods. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. |
| BG001 | Sequence 2: Placebo, VALTREX 1 g Once Daily | Participants randomized to this sequence received matching placebo for 60 days, to be taken as two 500 mg caplets in Period 1 followed by VALTREX 1 g once daily for 60 days in Period 2 with 7 days of washout period between 2 periods. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. |
| 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 | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Mean Percent Days of Subclinical Shedding as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for HSV-2 | Percent of subclinical days with HSV-2 shedding was defined for each participant as the percent of subclinical days with PCR data for which HSV-2 shedding was detected by a positive PCR result, that is, the number of subclinical days with HSV-2 PCR shedding divided by total number of subclinical days with PCR data, multiplied by 100. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or subclinical (no genital lesions). Genital/anal-rectal swabs was collected daily during each entire 60-day treatment period of each period and the washout period. | The intent-to-treat crossover (ITTC) population was defined as consisting of all participants who received at least one dose of investigational product and had at least one PCR swabbing result in each treatment period. Only those participants with data available at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | Percentage of days | Up to Day 60 of each treatment period (up to 160 days) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Percent Days of Total HSV-2 Shedding | The percent of days with total (clinical and subclinical) HSV-2 shedding was defined as the percent of all days with PCR data for which HSV-2 shedding was detected. Mean percent of days with total HSV-2 shedding was the statistic used to summarize this endpoint for each treatment group. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions). The total shedding rate was defined for each participant as the percentage of all days (clinical and subclinical) on treatment during which shedding was detected by PCR. Genital/anal-rectal swabs was collected daily during each entire 60-day treatment period of each period and the washout period. | ITTC population. Only those participants with data available at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | Percentage of days | Up to Day 60 of each treatment period (up to 160 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With no Shedding | The number of participants with no shedding was defined as the number of participants with no HSV-2 shedding detected by PCR divided by the total number of participants with PCR data. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions). | ITTC population. Only those participants with data available at the indicated time points were analyzed. | Posted | Count of Participants | Participants | Up to Day 60 of each treatment period (up to 160 days) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Log HSV-2 DNA Copy Number Per Day on Days With Subclinical Shedding | The subclinical shedding rate was defined for each participant as the total number of subclinical days on treatment during which shedding was detected by PCR. Average log HSV-2 DNA copy number per day on days with subclinical shedding was defined as the daily maximum HSV-2 DNA copy number was log transformed and averaged over all subclinical shedding days. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions). | ITTC population. Only those participants with data available at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | DNA copies per day | Up to Day 60 of each treatment period (up to 160 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Log HSV-2 DNA Copy Number Per Day on Days With Total Shedding | The total shedding rate was defined for each participant as the total number of all days (clinical and subclinical) on treatment during which shedding was detected by PCR. Average log HSV-2 DNA copy number per day on days with total shedding (clinical and subclinical) was defined as the daily maximum HSV-2 DNA copy number was log transformed and averaged over all shedding days. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions). | ITTC population. Only those participants with data available at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | DNA copies per day | Up to Day 60 of each treatment period (up to 160 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Overall Study Population Who Have Recognized Clinical Signs/Symptoms of Genital Herpes Infection During the Study | Participants who have recognized clinical signs/symptoms of genital herpes infection during the study. Participants were educated on recognizing signs and symptoms of genital herpes infection at the screening/randomization visit. Genital examinations was conducted at the randomization and genital herpes outbreak visits. | ITTC population. Only those participants with data available at the indicated time points were analyzed. | Posted | Number | Percentage of participants | Up to Day 60 of each treatment period (up to 160 days) |
|
Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
The ITTE population was used.
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 | Valtrex 1 g Once Daily | Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods. | 0 | 65 | 0 | 65 | 29 | 65 |
| EG001 | Placebo | Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods. | 0 | 63 | 1 | 63 | 42 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA version | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA version | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Vaginitis bacterial | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA version | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Stomach discomfort | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Oral soft tissue disorder | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA version | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA version | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA version | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA version | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
| |
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA version | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA version | Systematic Assessment |
| |
| Failure of implant | Injury, poisoning and procedural complications | MedDRA version | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA version | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA version | Systematic Assessment |
| |
| Neck injury | Injury, poisoning and procedural complications | MedDRA version | Systematic Assessment |
| |
| Breast tenderness | Reproductive system and breast disorders | MedDRA version | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA version | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA version | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA version | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA version | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA version | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA version | Systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA version | Systematic Assessment |
| |
| Metamyelocyte count increased | Investigations | MedDRA version | Systematic Assessment |
| |
| Myelocyte count increased | Investigations | MedDRA version | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA version | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version | Systematic Assessment |
| |
| Pruritus allergic | Skin and subcutaneous tissue disorders | MedDRA version | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA version | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA version | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA version | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA version | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA version | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D012008 | Recurrence |
| D006561 | Herpes Simplex |
| D006558 | Herpes Genitalis |
| ID | Term |
|---|---|
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077483 | Valacyclovir |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Other |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Placebo |
Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods. |
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| OG001 |
| Placebo |
Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods. |
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| OG001 | Placebo | Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods. |
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