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To demonstrate the efficacy of a single dose of acyclovir Lauriad® 50mg muco-adhesive buccal tablet versus a single dose of matching placebo on the primary vesicular lesion of cold sore.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Acyclovir Lauriad 50mg |
|
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acyclovir Lauriad | Drug | 50 mg muco-adhesive buccal tablets, single application on the gum |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Healing (TTH) of Vesicular Primary Lesion | Healing was defined as the loss of crust (erythema may be present) as assessed by the investigator. TTH was the time from treatment initiation to healing as defined above and was assessed from the time of treatment initiation through Day 14. The primary vesicular lesion was the first developed lesion located on the lip and was not to have extended more than 1 cm outside the lip. | Assessed from time of treatment initiation through Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Abortion of Primary Lesions | Aborted lesions were defined as herpetic lesions preceded by prodromal symptoms that did not progress beyond the papule stage. | Assessed from the time of treatment initiation through Day 14 |
| TTH of Non-primary Lesions (Aborted Lesions Excluded) |
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Inclusion Criteria:
History of recurrent herpes labialis lesions where:
Good general health (ECOG < 2), immunocompetent
Signed and dated written informed consent
Women of childbearing potential must have effective contraception method
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research, Inc., | Scottsdale | Arizona | 85251 | United States | ||
| Radiant Research, Inc., |
Per protocol, a total of 1950 patients were to be randomized. Following randomization, patients were not to start treatment until a new labial herpes episode occurred. Thus, of those randomized, only 780 patients were planned to be treated (390 patients per treatment group) and 1170 patients were to be randomized, but not treated.
Patients were screened beginning March 2007 and the last patient was treated in October 2008. The study was conducted at 47 sites in Australia, the Czech Republic, France, Germany, Poland, the United Kingdom and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acyclovir Lauriad Group | Acyclovir Lauriad 50mg muco-adhesive tablet |
| FG001 | Placebo Group | muco-adhesive buccal tablet with placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Drug |
50 mg muco-adhesive buccal tablets, single application on the gum |
|
TTH of non-primary lesions was defined as the time from treatment initiation to healing of all non-primary vesicular lesions. Non-primary lesions were those that developed in addition to and/or in 1 or more days after the primary vesicular lesion and that were located at least 1 cm from the primary lesion. Aborted lesions were not included in this parameter. TTH was to be assessed by the investigator. |
| Assessed from the time of treatment initiation through Day 14 |
| Duration of Episode (DOE) | For patients who experienced a vesicular lesion, DOE was defined as the time from treatment initiation to healing of primary and secondary vesicular lesions (loss of crust). For subjects whose primary and secondary lesions were not vesicular in nature, DOE was defied as the time from treatment initiation to return to normal skin or to cessation of symptoms, whichever came last. | Assessed from initiation of treatment to Day 14 |
| Time to Cessation of Symptoms | Time to cessation of symptoms was defined as the time from treatment initiation to cessation of all symptoms: pain, burning, itching, tingling, tenderness and discomfort. It was to be assessed by the investigator. | Assessed from time of treatment initiation through Day 14 |
| TTH of Aborted Primary Lesions | TTH of aborted primary lesions was defined as the time from treatment initiation to healing of the primary lesion (erythema or papule) or cessation of symptoms, whichever came last. It was to be assessed by the investigator. | Assessed from time of treatment initiation through Day 14 |
| Time to Recurrence of Non-aborted Lesions During 9-month Follow-up | Time to recurrence was the time from the healing of all lesions of the initial episode to the occurrence of new lesions. | From time of initial healing through the 9-month follow-up |
| Patient Incidence of Recurrence of Non-aborted Lesions During 9-month Follow-up | Recurrence was the occurrence of new lesions and was evaluated in a subgroup of patients who agreed to record recurrences during the 9-month follow-up period. | From time of initial healing through the 9-month follow-up |
| Symptom Intensity (Visual Analogue Scale [VAS]) | Patients were asked to place a tick mark on a 10 centimeter VAS indicating their symptom intensity. Scale ratings ranged from a minimum of 0 (none at all) to a maximum of 10 (worst possible). The location of the tick mark from "0" was measured in millimeters (0 - 100) and recorded. | Assessed on Days 1, 3, 5, 7 and 14 (or within 24 hours of healing) |
| Patient Satisfaction With Treatment | At the end of study (Day 14 [or within 24 hours of healing]), patients were asked whether they were satisfied with treatment (yes/no). | Assessed on Day 14 (or within 24 hours of healing) |
| Patient Assessment of Efficacy of the Treatment | At the end of study (Day 14 [ or within 24 hours of healing]), patients were asked to rate efficacy of treatment using a 4-point scale (inactive, mildly active, moderately active, or very active). | Assessed on Day 14 (or within 24 hours of healing) |
| Tucson |
| Arizona |
| 85710 |
| United States |
| Dermatology Private Practice | San Francisco | California | 94114 | United States |
| Front Range Clinical Research | Wheat Ridge | Colorado | 80033 | United States |
| St. Luke's Family Health, | Meridian | Idaho | 83642 | United States |
| Clinvest, a Division of Banyan Group, Inc., | Springfield | Missouri | 65807 | United States |
| Rochester Clinical Research, Inc., | Rochester | New York | 14609 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794-8091 | United States |
| Center for Clinical Studies | Houston | Texas | 77030 | United States |
| Center for Clinical Studies, Ltd., LLP. | Houston | Texas | 77058 | United States |
| Taylor Square Private Clinic | Sydney | Darlinghurst, NSW 2010 | Australia |
| Central Brunswick Medical Centre | Sydney | QLD 4006 | Australia |
| General Teaching Hospital, Dep. Of Dermatology | Opava | 128 08 Praha 2 | Czechia |
| U zastavky 16 | Opava | 747 00 | Czechia |
| Central military hospital Dept. of Dermatology | Prague | 169 02 Praha 6 | Czechia |
| University Hospital Bulovka 3rd Clinic of Inf. Diseases | Prague | 180 81 Praha 8 | Czechia |
| University Hospital Bulovka Dept. of Dermatology | Prague | 180 81 Praha 8 | Czechia |
| Hôpital St Jacques Service de Dermatologie | Besançon | 25030 BESANCON CEDEX | France |
| Private Practice | Martigues | 13500 | France |
| Hopital Fournier, Service de dermatologie | Nancy | 54000 | France |
| Private Practice | Nice | 06000 | France |
| Hôpital L'Archet 2, Service de Dermatologie | Nice | 06202 NICE Cedex | France |
| Private Practice | Paris | 75005 | France |
| Hôpital Tenon, Dermatology department | Paris | 75020 | France |
| Hôpital Saint Louis Paris, Service de Dermatologie 1 | Paris | 75475 PARIS Cedex 10 | France |
| Service de Stomatologie et chirurgie Maxilo-Faciale.Hôpital de la pitié Salpétrière | Paris | 75651 Paris Cedex 13 | France |
| Hôpital Nord, Service de dermatologie | Saint-Etienne | 42065 St ETIENNE Cedex 2 | France |
| Hôpital TROUSSEAU | Tours | 37044 TOURS Cedex | France |
| Praxis Dres. Dörzapf und Partner | Augsburg | 86153 | Germany |
| Charité Universitätsmedizin Berlin Klinik für Dermatologie, Venerologie und Allergologie | Berlin | 10117 | Germany |
| Praxis | Berlin | 10789 | Germany |
| Polikum Friedenau | Berlin | 12157 | Germany |
| Gemeinschaftspraxis | Berlin | 12353 | Germany |
| Laserclinic Drs. Steinert | Biberach | 88400 | Germany |
| Klinik und Poliklinik für Dermatologie des Universitätsklinikums Bonn | Bonn | 53105 | Germany |
| Praxis | Frankfurt | 60326 | Germany |
| Raiffeisenstr. 15b | Oberkirch | 77704 | Germany |
| Ludwig-Erhard-Platz 9-11 | Rodgau-Dudenhofen | Germany |
| Katedra i Klinika Dermatologii Collegium Medicum | Bydgoszcz | 85-096 | Poland |
| Centrum Medyczne Diabet | Chrzanów | 32-500 | Poland |
| Naukowo-Badawczy i Naukowo-Dydaktyczny Ośrodek Dermatologii Estetycznej, Dermatochirurgii i Fotodermatologii | Gdynia | 81-366 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej GCP Dobra Praktyka Lekarska | Grudziądz | 86-300 | Poland |
| NZOZ Atopia, Al. J. | Krakow | 31-159 | Poland |
| Specjalistyczne Gabinety Lekarskie Dermed | Lodz | 90-265 | Poland |
| Niepubliczny Zakład Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska Medikard | Płock | 09-402 | Poland |
| Niepubliczny Zakład Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną | Torun | 87-100 | Poland |
| Gabinet Internistyczny | Warsaw | 03-003 | Poland |
| NZOZ Praktyka Lekarska Iga Gilas - Mirkiewicz | Wroclaw | 50-354 | Poland |
| Cossington House Surgery | Canterbury | CT1 3HX | United Kingdom |
| School of Dentistry, Cardiff University | Cardiff | CF14 4XN | United Kingdom |
| Sidley Surgery | East Sussex | TN39 5HE | United Kingdom |
| Sea Road Surgery | East Sussex | TN40 1JJ | United Kingdom |
| Saltash Health Centre | Saltash | PL12 6DL | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acyclovir Lauriad Group | Acyclovir Lauriad 50mg muco-adhesive tablet/Intent-to-Treat population |
| BG001 | Placebo Group | muco-adhesive buccal tablet with placebo/Intent-to-Treat population |
| 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 | Data are provided for the Intent-to-Treat population. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Data are provided for the Intent-to-Treat population. | Count of Participants | Participants |
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| Region of Enrollment | Data are provided for the Intent-to-Treat population. | Number | participants |
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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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Abortion of Primary Lesions | Aborted lesions were defined as herpetic lesions preceded by prodromal symptoms that did not progress beyond the papule stage. | This endpoint was analyzed using the Intent-to-Treat (ITT) population, which consisted of all randomized patients who received at least one dose of study medication and who had complete information recorded for the application time. | Posted | Number | participants | Assessed from the time of treatment initiation through Day 14 |
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| Secondary | TTH of Non-primary Lesions (Aborted Lesions Excluded) | TTH of non-primary lesions was defined as the time from treatment initiation to healing of all non-primary vesicular lesions. Non-primary lesions were those that developed in addition to and/or in 1 or more days after the primary vesicular lesion and that were located at least 1 cm from the primary lesion. Aborted lesions were not included in this parameter. TTH was to be assessed by the investigator. | This endpoint was analyzed using a subgroup of patients in the ITT population with non-primary lesions. | Posted | Median | 95% Confidence Interval | Days | Assessed from the time of treatment initiation through Day 14 |
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| Secondary | Duration of Episode (DOE) | For patients who experienced a vesicular lesion, DOE was defined as the time from treatment initiation to healing of primary and secondary vesicular lesions (loss of crust). For subjects whose primary and secondary lesions were not vesicular in nature, DOE was defied as the time from treatment initiation to return to normal skin or to cessation of symptoms, whichever came last. | This endpoint was analyzed using the ITT population. | Posted | Median | 95% Confidence Interval | Days | Assessed from initiation of treatment to Day 14 |
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| Secondary | Time to Cessation of Symptoms | Time to cessation of symptoms was defined as the time from treatment initiation to cessation of all symptoms: pain, burning, itching, tingling, tenderness and discomfort. It was to be assessed by the investigator. | This endpoint was analyzed using the ITT population. | Posted | Median | 95% Confidence Interval | Days | Assessed from time of treatment initiation through Day 14 |
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| Secondary | TTH of Aborted Primary Lesions | TTH of aborted primary lesions was defined as the time from treatment initiation to healing of the primary lesion (erythema or papule) or cessation of symptoms, whichever came last. It was to be assessed by the investigator. | This endpoint was analyzed using the subgroup of patients within the ITT population with aborted lesions. | Posted | Median | 95% Confidence Interval | Days | Assessed from time of treatment initiation through Day 14 |
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| Primary | Time to Healing (TTH) of Vesicular Primary Lesion | Healing was defined as the loss of crust (erythema may be present) as assessed by the investigator. TTH was the time from treatment initiation to healing as defined above and was assessed from the time of treatment initiation through Day 14. The primary vesicular lesion was the first developed lesion located on the lip and was not to have extended more than 1 cm outside the lip. | The modified Intent-to-Treat (mITT) population was the population used for analysis of this endpoint. The mITT population included all randomized patients who received at least one dose of study medication and who reached the vesicular stage (ie, episodes that progressed through macula, papule, vesicle, crust and healing). | Posted | Median | 95% Confidence Interval | Days | Assessed from time of treatment initiation through Day 14 |
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| Secondary | Time to Recurrence of Non-aborted Lesions During 9-month Follow-up | Time to recurrence was the time from the healing of all lesions of the initial episode to the occurrence of new lesions. | This endpoint was analyzed using the follow-up population, a subgroup of the ITT population who continued to the 9 month follow-up and had at least 1 diary assessment during that period. The follow-up population was defined as patients whose lesions were healed at the end of Day 14 and had no recurrence within 15 days of healing of all lesions. | Posted | Median | 95% Confidence Interval | Days | From time of initial healing through the 9-month follow-up |
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| Secondary | Patient Incidence of Recurrence of Non-aborted Lesions During 9-month Follow-up | Recurrence was the occurrence of new lesions and was evaluated in a subgroup of patients who agreed to record recurrences during the 9-month follow-up period. | This endpoint was analyzed using the follow-up population, a subgroup of the ITT population who continued to the 9 month follow-up and had at least 1 diary assessment during that period. The follow-up population was defined as patients whose lesions were healed at the end of Day 14 and had no recurrence within 15 days of healing of all lesions. | Posted | Number | participants | From time of initial healing through the 9-month follow-up |
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| Secondary | Symptom Intensity (Visual Analogue Scale [VAS]) | Patients were asked to place a tick mark on a 10 centimeter VAS indicating their symptom intensity. Scale ratings ranged from a minimum of 0 (none at all) to a maximum of 10 (worst possible). The location of the tick mark from "0" was measured in millimeters (0 - 100) and recorded. | This endpoint was analyzed using the safety population, which consisted of all randomized patients who took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | units on a scale (0 - 100) | Assessed on Days 1, 3, 5, 7 and 14 (or within 24 hours of healing) |
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| Secondary | Patient Satisfaction With Treatment | At the end of study (Day 14 [or within 24 hours of healing]), patients were asked whether they were satisfied with treatment (yes/no). | This endpoint was analyzed using the ITT population. | Posted | Number | participants | Assessed on Day 14 (or within 24 hours of healing) |
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| Secondary | Patient Assessment of Efficacy of the Treatment | At the end of study (Day 14 [ or within 24 hours of healing]), patients were asked to rate efficacy of treatment using a 4-point scale (inactive, mildly active, moderately active, or very active). | This endpoint was analyzed using the ITT population. | Posted | Number | participants | Assessed on Day 14 (or within 24 hours of healing) |
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Adverse events were recorded during the 14 day treatment period.
The safety population included all randomized patients who took at least 1 dose of study drug, including 378 patients in the acyclovir Lauriad group and 397 patients in the placebo group.
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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 | Acyclovir Lauriad Group | Acyclovir Lauriad 50mg muco-adhesive tablet | 0 | 378 | 20 | 378 | ||
| EG001 | Placebo Group | muco-adhesive buccal tablet with placebo | 1 | 397 | 22 | 397 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction | Immune system disorders | hypersensitivity | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | headache | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Nasopharyngitis | Non-systematic Assessment |
| |
| Application Site Pain | General disorders | application Site Pai | Non-systematic Assessment |
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| nausea | Gastrointestinal disorders | nausea | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Pierre ATTALI | BioAlliance Pharma | +33145587600 | pierre.attali@bioalliancepharma.com |
| ID | Term |
|---|---|
| D006560 | Herpes Labialis |
| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D017193 | Skin Diseases, Viral |
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
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| Male |
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| France |
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| Czech Republic |
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| Poland |
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| Australia |
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| Germany |
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| United Kingdom |
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| Aborted Lesions = Missing |
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