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| Name | Class |
|---|---|
| Norwich Clinical Research Associates Ltd. | OTHER |
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The purpose of this study is to determine if a new treatment is effective for the treatment of recurrent symptomatic oral herpes virus infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTL TML HSV | Experimental |
| |
| Matching Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTL TML HSV | Drug | Sublingual micro-dosing for 7 days |
| |
| Matching placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Who Experience a New Cold Sore Outbreak That Proceeds to the Lesion Stage. Of Those Subjects That Take Study Medication (Experience a New Emerging Cold Sore) Those That Proceed to Lesion Stage (Cold Sore Stage - 3 Vesicle or Above). | Subjects start a daily diary based on start of symptoms of a new emerging cold sore and start taking study medication. Subjects note the start time of study medication along with cold sore stage(s)for at least 7 days and up to 14 days. Subjects take study medication for 7 days. Cold Sore stages are 0=Dormant, 1=Prodrome, 2=Inflammation, 3=Vesicle, 4=Ulcer, 5=Crust, 6=Healed. If subjects do not experience a new cold sore outbreak within 7 days, they do not take study medication and are completed with the study. | 7-14 days (depending on time of lesion outbreak - subjects had 7 days to experience a new emerging cold sore) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky College of Dentistry/Center for Oral Health Research | Lexington | Kentucky | 40536 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35142535 | Derived | Mamber SW, Hatch T, Miller CS, Murray JV, Strout C, McMichael J. Low-dose Oral Thimerosal for the Treatment of Oral Herpes: Clinical Trial Results and Improved Outcome After Post-hoc Analysis. J Evid Based Integr Med. 2022 Jan-Dec;27:2515690X221078004. doi: 10.1177/2515690X221078004. |
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Participants entered a baseline run in period to assess eligibility before randomization and dental procedure.
Participants were recruited from four dental clinics in the USA during the study period of 1/26/11 - 9/14/2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Baseline Run In | Baseline period to assess eligibility before randomization |
| FG001 | Matching Placebo | Matching placebo : sublingual dosing for 7 days |
| FG002 | BTL TML HSV | BTL TML HSV : Sublingual micro-dosing for 7 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Eligibility |
|
| ||||||||||||||||||
| Randomization |
|
Subjects randomized into the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Matching Placebo | Matching placebo : sublingual dosing for 7 days |
| BG001 | BTL TML HSV | BTL TML HSV : Sublingual micro-dosing for 7 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Proportion of Subjects Who Experience a New Cold Sore Outbreak That Proceeds to the Lesion Stage. Of Those Subjects That Take Study Medication (Experience a New Emerging Cold Sore) Those That Proceed to Lesion Stage (Cold Sore Stage - 3 Vesicle or Above). | Subjects start a daily diary based on start of symptoms of a new emerging cold sore and start taking study medication. Subjects note the start time of study medication along with cold sore stage(s)for at least 7 days and up to 14 days. Subjects take study medication for 7 days. Cold Sore stages are 0=Dormant, 1=Prodrome, 2=Inflammation, 3=Vesicle, 4=Ulcer, 5=Crust, 6=Healed. If subjects do not experience a new cold sore outbreak within 7 days, they do not take study medication and are completed with the study. | As randomized subjects waited until reoccurrence of cold sore lesions, 23/87 participants in the placebo treatment group and 9/84 in the BTL-TML-HSV group took study medication and were eligible for the primary outcome. | Posted | Number | percentage of Participants | 7-14 days (depending on time of lesion outbreak - subjects had 7 days to experience a new emerging cold sore) |
|
Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
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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 | Baseline Run In | Baseline period to assess eligibility before randomization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post Colonoscopy bowel perforation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment | Subject developed complications during a routine colonoscopy procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John McMichael | Beech Tree Labs, Inc. | 518-872-1144 |
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| ID | Term |
|---|---|
| D013283 | Stomatitis, Herpetic |
| D006560 | Herpes Labialis |
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| Drug |
sublingual dosing for 7 days |
|
| School of Dental Medicine, University at Buffalo |
| Buffalo |
| New York |
| 14214 |
| United States |
| Family Dentistry | Norwich | New York | 13815 | United States |
| University of Pittsburgh School of Dental Medicine | Pittsburgh | Pennsylvania | 15261 | United States |
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Matching Placebo | Matching placebo : sublingual dosing for 7 days |
| OG001 | BTL TML HSV | BTL TML HSV : Sublingual micro-dosing for 7 days |
|
|
| 0 |
| 71 |
| 0 |
| 71 |
| EG001 | Matching Placebo | Matching placebo : sublingual dosing for 7 days | 2 | 87 | 32 | 87 |
| EG002 | BTL TML HSV | BTL TML HSV : Sublingual micro-dosing for 7 days | 0 | 84 | 29 | 84 |
|
| Low Blood Volume | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Oral lesion | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| High protein urine | Investigations | MedDRA (11.0) | Systematic Assessment | Labs could have been taken at baseline prior to randomization. |
|
| High Red Blood Cells urine | Investigations | MedDRA (11.0) | Systematic Assessment | Labs could have been taken at baseline prior to randomization. |
|
| Urine ketone body | Investigations | MedDRA (11.0) | Systematic Assessment | Labs could have been taken at baseline prior to randomization. |
|
| Urine White Blood Cells | Investigations | MedDRA (11.0) | Systematic Assessment | Labs could have been taken at baseline prior to randomization. |
|
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| D013280 |
| Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D017193 | Skin Diseases, Viral |
| D008047 | Lip Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |