Phase 3 Clinical Study for the Treatment of Cold Sore (LIP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioAlliance Pharma SA
ClinicalTrials.gov Identifier:
NCT00769314
First received: October 8, 2008
Last updated: November 21, 2012
Last verified: November 2012
Results First Received: October 26, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Herpes Labialis
Interventions: Drug: Acyclovir Lauriad
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Acyclovir Lauriad Group Acyclovir Lauriad 50mg muco-adhesive tablet
Placebo Group muco-adhesive buccal tablet with placebo

Participant Flow:   Overall Study
    Acyclovir Lauriad Group     Placebo Group  
STARTED     378 [1]   397 [1]
COMPLETED     361     384  
NOT COMPLETED     17     13  
[1] The number of participants started is defined as those that were randomized and received treatment.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Acyclovir Lauriad Group Acyclovir Lauriad 50mg muco-adhesive tablet/Intent-to-Treat population
Placebo Group muco-adhesive buccal tablet with placebo/Intent-to-Treat population
Total Total of all reporting groups

Baseline Measures
    Acyclovir Lauriad Group     Placebo Group     Total  
Number of Participants  
[units: participants]
  376     395     771  
Age [1]
[units: years]
Mean ± Standard Deviation
  40  ± 12.97     41.9  ± 13.33     41.0  ± 13.18  
Gender [1]
[units: participants]
     
Female     258     271     529  
Male     118     124     242  
Region of Enrollment [1]
[units: participants]
     
United States     71     72     143  
France     41     49     90  
Czech Republic     47     50     97  
Poland     74     70     144  
Australia     53     68     121  
Germany     79     77     156  
United Kingdom     11     9     20  
[1] Data are provided for the Intent-to-Treat population.



  Outcome Measures
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1.  Primary:   Time to Healing (TTH) of Vesicular Primary Lesion   [ Time Frame: Assessed from time of treatment initiation through Day 14 ]

2.  Secondary:   Abortion of Primary Lesions   [ Time Frame: Assessed from the time of treatment initiation through Day 14 ]

3.  Secondary:   TTH of Non-primary Lesions (Aborted Lesions Excluded)   [ Time Frame: Assessed from the time of treatment initiation through Day 14 ]

4.  Secondary:   Duration of Episode (DOE)   [ Time Frame: Assessed from initiation of treatment to Day 14 ]

5.  Secondary:   Time to Cessation of Symptoms   [ Time Frame: Assessed from time of treatment initiation through Day 14 ]

6.  Secondary:   TTH of Aborted Primary Lesions   [ Time Frame: Assessed from time of treatment initiation through Day 14 ]

7.  Secondary:   Time to Recurrence of Non-aborted Lesions During 9-month Follow-up   [ Time Frame: From time of initial healing through the 9-month follow-up ]

8.  Secondary:   Patient Incidence of Recurrence of Non-aborted Lesions During 9-month Follow-up   [ Time Frame: From time of initial healing through the 9-month follow-up ]

9.  Secondary:   Symptom Intensity (Visual Analogue Scale [VAS])   [ Time Frame: Assessed on Days 1, 3, 5, 7 and 14 (or within 24 hours of healing) ]

10.  Secondary:   Patient Satisfaction With Treatment   [ Time Frame: Assessed on Day 14 (or within 24 hours of healing) ]

11.  Secondary:   Patient Assessment of Efficacy of the Treatment   [ Time Frame: Assessed on Day 14 (or within 24 hours of healing) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Pierre ATTALI
Organization: BioAlliance Pharma
phone: +33145587600
e-mail: pierre.attali@bioalliancepharma.com


No publications provided


Responsible Party: BioAlliance Pharma SA
ClinicalTrials.gov Identifier: NCT00769314     History of Changes
Other Study ID Numbers: BA2005/21/02
Study First Received: October 8, 2008
Results First Received: October 26, 2011
Last Updated: November 21, 2012
Health Authority: United States: Food and Drug Administration