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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00769314
Registration number
NCT00769314
Ethics application status
Date submitted
8/10/2008
Date registered
9/10/2008
Date last updated
21/12/2012
Titles & IDs
Public title
Phase 3 Clinical Study for the Treatment of Cold Sore
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Scientific title
A Randomised, Double-Blind, Single Dose, One-Day Early Administration, Multicentre Study Comparing the Efficacy and Safety of Acyclovir Lauriad® 50 mg Muco-adhesive Buccal Tablet to Matching Placebo, in the Treatment of Herpes Labialis in Immunocompetent Patients.
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Secondary ID [1]
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BA2005/21/02
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Universal Trial Number (UTN)
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Trial acronym
LIP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Herpes Labialis
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Condition category
Condition code
Infection
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Other infectious diseases
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Acyclovir Lauriad
Treatment: Drugs - Placebo
Experimental: 1 - Acyclovir Lauriad 50mg
Placebo comparator: 2 -
Treatment: Drugs: Acyclovir Lauriad
50 mg muco-adhesive buccal tablets, single application on the gum
Treatment: Drugs: Placebo
50 mg muco-adhesive buccal tablets, single application on the gum
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to Healing (TTH) of Vesicular Primary Lesion
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Assessment method [1]
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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.
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Timepoint [1]
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Assessed from time of treatment initiation through Day 14
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Secondary outcome [1]
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Abortion of Primary Lesions
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Assessment method [1]
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Aborted lesions were defined as herpetic lesions preceded by prodromal symptoms that did not progress beyond the papule stage.
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Timepoint [1]
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Assessed from the time of treatment initiation through Day 14
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Secondary outcome [2]
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TTH of Non-primary Lesions (Aborted Lesions Excluded)
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Assessment method [2]
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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.
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Timepoint [2]
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Assessed from the time of treatment initiation through Day 14
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Secondary outcome [3]
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Duration of Episode (DOE)
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Assessment method [3]
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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.
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Timepoint [3]
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Assessed from initiation of treatment to Day 14
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Secondary outcome [4]
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Time to Cessation of Symptoms
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Assessment method [4]
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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.
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Timepoint [4]
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Assessed from time of treatment initiation through Day 14
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Secondary outcome [5]
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TTH of Aborted Primary Lesions
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Assessment method [5]
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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.
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Timepoint [5]
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Assessed from time of treatment initiation through Day 14
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Secondary outcome [6]
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Time to Recurrence of Non-aborted Lesions During 9-month Follow-up
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Assessment method [6]
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Time to recurrence was the time from the healing of all lesions of the initial episode to the occurrence of new lesions.
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Timepoint [6]
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From time of initial healing through the 9-month follow-up
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Secondary outcome [7]
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Patient Incidence of Recurrence of Non-aborted Lesions During 9-month Follow-up
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Assessment method [7]
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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.
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Timepoint [7]
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From time of initial healing through the 9-month follow-up
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Secondary outcome [8]
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Symptom Intensity (Visual Analogue Scale [VAS])
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Assessment method [8]
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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.
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Timepoint [8]
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Assessed on Days 1, 3, 5, 7 and 14 (or within 24 hours of healing)
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Secondary outcome [9]
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Patient Satisfaction With Treatment
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Assessment method [9]
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At the end of study (Day 14 \[or within 24 hours of healing\]), patients were asked whether they were satisfied with treatment (yes/no).
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Timepoint [9]
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Assessed on Day 14 (or within 24 hours of healing)
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Secondary outcome [10]
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Patient Assessment of Efficacy of the Treatment
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Assessment method [10]
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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).
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Timepoint [10]
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Assessed on Day 14 (or within 24 hours of healing)
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Eligibility
Key inclusion criteria
* History of recurrent herpes labialis lesions where:
* At least 50% of previous episodes produced classical lesions to the vesicular stage (i.e. episodes that progressed through macula, papule, vesicle, crust and healed);
* Prodromal symptoms (itching, tingling, pain etc.) should precede herpes labialis lesions in at least 50% of the previous herpes episodes
* Good general health (ECOG < 2), immunocompetent
* Signed and dated written informed consent
* Women of childbearing potential must have effective contraception method
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* More than 50% of recurrences that aborted spontaneously in the past 12 months
* Primary herpes lesion outside the lips (e.g. nose, chin, etc.)
* Abnormal peri-oral skin condition that might affect the normal course of cold sores (e.g. eczema, psoriasis...)
* Oral diseases whose prodromal symptoms may mimick those of herpes labialis, including recurrent oral aphthous disease
* Oral diseases that might interfere with the evaluation of the efficacy or safety of the treatments, including gingivitis, parondotis, mucositis, oropharyngeal candidiasis...
* History of infection known to be resistant to acyclovir family agents
* Previous vaccination against herpes
* Concomitant treatment likely to interfere with acyclovir
* Allergy to any acyclovir containing agents
* Immunocompromised condition, including HIV+
* Unability to properly understand protocol requirements, to follow the study procedures, to complete the patient diary or to start the self-initiation of the treatment
* Upper full or partial dentures with acrylic border in the canine fossa
* Milk allergy or known history of hypersensitivity to one of the components of the products
* Rare hereditary problems of galactose intolerance.
* Lactase enzyme deficiency or glucose galactose malabsorption
* Clinically significant abnormal level of serum creatinine
* Patients whose occupations make them unlikely to return to the clinic within 24h of treatment initiation
* Pregnancy or breast-feeding
* Investigational drug or immunomodulator treatment in the 30 days prior randomisation
* Prior enrollment in this study
* Participation in another therapeutic trial evaluating new drugs or which could interfere with the evolution of herpes labialis or the evaluation of the drug in the study within preceding 30 day.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
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Actual
1/08/2009
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Sample size
Target
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Accrual to date
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Final
1727
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Taylor Square Private Clinic - Sydney
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Recruitment hospital [2]
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Central Brunswick Medical Centre - Sydney
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Recruitment postcode(s) [1]
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Darlinghurst, NSW 2010 - Sydney
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Recruitment postcode(s) [2]
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QLD 4006 - Sydney
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Idaho
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Missouri
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New York
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Texas
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Czech Republic
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Opava
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Czech Republic
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Praha
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France
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Besancon
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France
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Martigues
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France
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Nancy
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France
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Nice
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France
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Paris
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France
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St. Etienne
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France
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Tours
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Germany
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Augsburg
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Germany
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Berlin
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Germany
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Biberach
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Germany
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Bonn
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Germany
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Frankfurt
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Germany
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Oberkirch
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Germany
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Rodgau-Dudenhofen
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Bydgoszcz
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Chrzanów
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Gdynia
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Grudziadz
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Kraków
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Plock
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Torun
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Warszawa
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Wroclaw
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Lódz
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United Kingdom
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Canterbury
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Cardiff
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East Sussex
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United Kingdom
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Saltash
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Valerio Therapeutics
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/study/NCT00769314
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00769314
Download to PDF