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

History of Changes

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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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 ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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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 ]

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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 ]

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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) ]

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10. Secondary:

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

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11. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

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.

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

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