Safety and Efficacy Study of a New Treatment for Recurrent Symptoms of Oral Herpes Virus Infection

This study has been completed.
Sponsor:
Collaborator:
Norwich Clinical Research Associates Ltd.
Information provided by (Responsible Party):
Beech Tree Labs, Inc.
ClinicalTrials.gov Identifier:
NCT01308424
First received: March 2, 2011
Last updated: August 12, 2013
Last verified: August 2013
Results First Received: May 22, 2013  
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: Oral Herpes Simplex
Interventions: Drug: BTL TML HSV
Drug: Matching placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from four dental clinics in the USA during the study period of 1/26/11 - 9/14/2012

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants entered a baseline run in period to assess eligibility before randomization and dental procedure.

Reporting Groups
  Description
Baseline Run In Baseline period to assess eligibility before randomization
Matching Placebo Matching placebo : sublingual dosing for 7 days
BTL TML HSV BTL TML HSV : Sublingual micro-dosing for 7 days

Participant Flow for 2 periods

Period 1:   Baseline Eligibility
    Baseline Run In     Matching Placebo     BTL TML HSV  
STARTED     242     0     0  
COMPLETED     171 [1]   0     0  
NOT COMPLETED     71     0     0  
Screen Failures                 71                 0                 0  
[1] Completed baseline run in and were eligible for randomization

Period 2:   Randomization
    Baseline Run In     Matching Placebo     BTL TML HSV  
STARTED     0     87     84  
COMPLETED     0     84     82  
NOT COMPLETED     0     3     2  
Adverse Event                 0                 1                 1  
Lost to Follow-up                 0                 1                 0  
Physician Decision                 0                 1                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Subjects randomized into the study.

Reporting Groups
  Description
Matching Placebo Matching placebo : sublingual dosing for 7 days
BTL TML HSV BTL TML HSV : Sublingual micro-dosing for 7 days
Total Total of all reporting groups

Baseline Measures
    Matching Placebo     BTL TML HSV     Total  
Number of Participants  
[units: participants]
  87     84     171  
Age  
[units: years]
Mean ( Full Range )
  41.6  
  ( 19.2 to 70.7 )  
  45.2  
  ( 20.0 to 76.9 )  
  43.3  
  ( 19.2 to 76.9 )  
Gender  
[units: participants]
     
Female     55     61     116  
Male     32     23     55  
Region of Enrollment  
[units: participants]
     
United States     87     84     171  



  Outcome Measures

1.  Primary:   Proportion of Subjects Who Experience a New Cold Sore Outbreak That Proceeds to the Lesion Stage. Of Those Subjects That Take Study Medication (Experience a New Emerging Cold Sore) Those That Proceed to Lesion Stage (Cold Sore Stage - 3 Vesicle or Above).   [ Time Frame: 7-14 days (depending on time of lesion outbreak - subjects had 7 days to experience a new emerging cold sore) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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 less than or equal to 60 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. John McMichael
Organization: Beech Tree Labs, Inc.
phone: 518-872-1144


No publications provided


Responsible Party: Beech Tree Labs, Inc.
ClinicalTrials.gov Identifier: NCT01308424     History of Changes
Other Study ID Numbers: 2010-03-0112
Study First Received: March 2, 2011
Results First Received: May 22, 2013
Last Updated: August 12, 2013
Health Authority: United States: Food and Drug Administration