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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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.
Secondary ID [1] 0 0
BA2005/21/02
Universal Trial Number (UTN)
Trial acronym
LIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Herpes Labialis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Assessed from time of treatment initiation through Day 14
Secondary outcome [1] 0 0
Abortion of Primary Lesions - Aborted lesions were defined as herpetic lesions preceded by prodromal symptoms that did not progress beyond the papule stage.
Timepoint [1] 0 0
Assessed from the time of treatment initiation through Day 14
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Assessed from the time of treatment initiation through Day 14
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Assessed from initiation of treatment to Day 14
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Assessed from time of treatment initiation through Day 14
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Assessed from time of treatment initiation through Day 14
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
From time of initial healing through the 9-month follow-up
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
From time of initial healing through the 9-month follow-up
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Assessed on Days 1, 3, 5, 7 and 14 (or within 24 hours of healing)
Secondary outcome [9] 0 0
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).
Timepoint [9] 0 0
Assessed on Day 14 (or within 24 hours of healing)
Secondary outcome [10] 0 0
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).
Timepoint [10] 0 0
Assessed on Day 14 (or within 24 hours of healing)

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Taylor Square Private Clinic - Sydney
Recruitment hospital [2] 0 0
Central Brunswick Medical Centre - Sydney
Recruitment postcode(s) [1] 0 0
Darlinghurst, NSW 2010 - Sydney
Recruitment postcode(s) [2] 0 0
QLD 4006 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Opava
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Praha
Country [10] 0 0
France
State/province [10] 0 0
Besancon
Country [11] 0 0
France
State/province [11] 0 0
Martigues
Country [12] 0 0
France
State/province [12] 0 0
Nancy
Country [13] 0 0
France
State/province [13] 0 0
Nice
Country [14] 0 0
France
State/province [14] 0 0
Paris
Country [15] 0 0
France
State/province [15] 0 0
St. Etienne
Country [16] 0 0
France
State/province [16] 0 0
Tours
Country [17] 0 0
Germany
State/province [17] 0 0
Augsburg
Country [18] 0 0
Germany
State/province [18] 0 0
Berlin
Country [19] 0 0
Germany
State/province [19] 0 0
Biberach
Country [20] 0 0
Germany
State/province [20] 0 0
Bonn
Country [21] 0 0
Germany
State/province [21] 0 0
Frankfurt
Country [22] 0 0
Germany
State/province [22] 0 0
Oberkirch
Country [23] 0 0
Germany
State/province [23] 0 0
Rodgau-Dudenhofen
Country [24] 0 0
Poland
State/province [24] 0 0
Bydgoszcz
Country [25] 0 0
Poland
State/province [25] 0 0
Chrzanów
Country [26] 0 0
Poland
State/province [26] 0 0
Gdynia
Country [27] 0 0
Poland
State/province [27] 0 0
Grudziadz
Country [28] 0 0
Poland
State/province [28] 0 0
Kraków
Country [29] 0 0
Poland
State/province [29] 0 0
Plock
Country [30] 0 0
Poland
State/province [30] 0 0
Torun
Country [31] 0 0
Poland
State/province [31] 0 0
Warszawa
Country [32] 0 0
Poland
State/province [32] 0 0
Wroclaw
Country [33] 0 0
Poland
State/province [33] 0 0
Lódz
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Canterbury
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Cardiff
Country [36] 0 0
United Kingdom
State/province [36] 0 0
East Sussex
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Saltash

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Onxeo
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00769314
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications