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: March 5, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	March 2, 2011
Last Updated Date	March 5, 2013
Start Date ^ICMJE	January 2011
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 2, 2011)	Symptomatic lesions of a oral herpes simplex outbreak [ Time Frame: Daily for 7 days ] [ Designated as safety issue: No ] Lesion classification based on diary card and investigator assessment
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01308424 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 2, 2011)	Number of participants with adverse events [ Time Frame: The course of the study ] [ Designated as safety issue: Yes ] Review of adverse experiences, laboratory values to access patient safety
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study of a New Treatment for Recurrent Symptoms of Oral Herpes Virus Infection
Official Title ^ICMJE	A Randomized, Double-blind, Parallel, Placebo-controlled Study for the Assessment of the Safety and Efficacy of BTL-TML-HSV for the Treatment of Recurrent Symptomatic Oral Herpes Virus Infection
Brief Summary	The purpose of this study is to determine if a new treatment is effective for the treatment of recurrent symptomatic oral herpes virus infections.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Oral Herpes Simplex
Intervention ^ICMJE	Drug: BTL TML HSV Sublingual micro-dosing for 7 days Drug: Matching placebo sublingual dosing for 7 days
Study Arm (s)	Experimental: BTL TML HSV Intervention: Drug: BTL TML HSV Placebo Comparator: Matching Placebo Intervention: Drug: Matching placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	171
Completion Date	November 2012
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Clinical history of recurrent cold sores averaging 2 or more episodes per year Experiences prodromal symptoms (tingling, burning, itching) of cold sores Herpes Simplex Virus ser0positive (by blood test) Exclusion Criteria: Immuno-suppressed or taking immunosuppressant medication Use of antiviral therapy directly prior and during the study
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01308424
Other Study ID Numbers ^ICMJE	2010-03-0112
Has Data Monitoring Committee	No
Responsible Party	Beech Tree Labs, Inc.
Study Sponsor ^ICMJE	Beech Tree Labs, Inc.
Collaborators ^ICMJE	Norwich Clinical Research Associates LTD
Investigators ^ICMJE	Not Provided
Information Provided By	Beech Tree Labs, Inc.
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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