Trial Outcomes & Findings for Safety and Efficacy Study of a New Treatment for Recurrent Symptoms of Oral Herpes Virus Infection (NCT NCT01308424)
NCT ID: NCT01308424
Last Updated: 2013-08-13
Results Overview
Subjects start a daily diary based on start of symptoms of a new emerging cold sore and start taking study medication. Subjects note the start time of study medication along with cold sore stage(s)for at least 7 days and up to 14 days. Subjects take study medication for 7 days. Cold Sore stages are 0=Dormant, 1=Prodrome, 2=Inflammation, 3=Vesicle, 4=Ulcer, 5=Crust, 6=Healed. If subjects do not experience a new cold sore outbreak within 7 days, they do not take study medication and are completed with the study.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
171 participants
Primary outcome timeframe
7-14 days (depending on time of lesion outbreak - subjects had 7 days to experience a new emerging cold sore)
Results posted on
2013-08-13
Participant Flow
Participants were recruited from four dental clinics in the USA during the study period of 1/26/11 - 9/14/2012
Participants entered a baseline run in period to assess eligibility before randomization and dental procedure.
Participant milestones
| Measure |
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
|
|---|---|---|---|
|
Baseline Eligibility
STARTED
|
242
|
0
|
0
|
|
Baseline Eligibility
COMPLETED
|
171
|
0
|
0
|
|
Baseline Eligibility
NOT COMPLETED
|
71
|
0
|
0
|
|
Randomization
STARTED
|
0
|
87
|
84
|
|
Randomization
COMPLETED
|
0
|
84
|
82
|
|
Randomization
NOT COMPLETED
|
0
|
3
|
2
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|
|
Baseline Eligibility
Screen Failures
|
71
|
0
|
0
|
|
Randomization
Adverse Event
|
0
|
1
|
1
|
|
Randomization
Lost to Follow-up
|
0
|
1
|
0
|
|
Randomization
Physician Decision
|
0
|
1
|
1
|
Baseline Characteristics
Safety and Efficacy Study of a New Treatment for Recurrent Symptoms of Oral Herpes Virus Infection
Baseline characteristics by cohort
| Measure |
Matching Placebo
n=87 Participants
Matching placebo : sublingual dosing for 7 days
|
BTL TML HSV
n=84 Participants
BTL TML HSV : Sublingual micro-dosing for 7 days
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
41.6 years
n=5 Participants
|
45.2 years
n=7 Participants
|
43.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
87 participants
n=5 Participants
|
84 participants
n=7 Participants
|
171 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7-14 days (depending on time of lesion outbreak - subjects had 7 days to experience a new emerging cold sore)Population: As randomized subjects waited until reoccurrence of cold sore lesions, 23/87 participants in the placebo treatment group and 9/84 in the BTL-TML-HSV group took study medication and were eligible for the primary outcome.
Subjects start a daily diary based on start of symptoms of a new emerging cold sore and start taking study medication. Subjects note the start time of study medication along with cold sore stage(s)for at least 7 days and up to 14 days. Subjects take study medication for 7 days. Cold Sore stages are 0=Dormant, 1=Prodrome, 2=Inflammation, 3=Vesicle, 4=Ulcer, 5=Crust, 6=Healed. If subjects do not experience a new cold sore outbreak within 7 days, they do not take study medication and are completed with the study.
Outcome measures
| Measure |
Matching Placebo
n=23 Participants
Matching placebo : sublingual dosing for 7 days
|
BTL TML HSV
n=9 Participants
BTL TML HSV : Sublingual micro-dosing for 7 days
|
|---|---|---|
|
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).
|
77.8 percentage of Participants
|
45.5 percentage of Participants
|
Adverse Events
Baseline Run In
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
BTL TML HSV
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Baseline Run In
n=71 participants at risk
Baseline period to assess eligibility before randomization
|
Matching Placebo
n=87 participants at risk
Matching placebo : sublingual dosing for 7 days
|
BTL TML HSV
n=84 participants at risk
BTL TML HSV : Sublingual micro-dosing for 7 days
|
|---|---|---|---|
|
Gastrointestinal disorders
Post Colonoscopy bowel perforation
|
0.00%
0/71 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
0.00%
0/84 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
|
Blood and lymphatic system disorders
Low Blood Volume
|
0.00%
0/71 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
0.00%
0/84 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
Other adverse events
| Measure |
Baseline Run In
n=71 participants at risk
Baseline period to assess eligibility before randomization
|
Matching Placebo
n=87 participants at risk
Matching placebo : sublingual dosing for 7 days
|
BTL TML HSV
n=84 participants at risk
BTL TML HSV : Sublingual micro-dosing for 7 days
|
|---|---|---|---|
|
Gastrointestinal disorders
Oral lesion
|
0.00%
0/71 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
6.9%
6/87 • Number of events 7 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
1.2%
1/84 • Number of events 1 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
|
Investigations
High protein urine
|
0.00%
0/71 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
8.0%
7/87 • Number of events 7 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
4.8%
4/84 • Number of events 4 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
|
Investigations
High Red Blood Cells urine
|
0.00%
0/71 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
5.7%
5/87 • Number of events 5 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
7.1%
6/84 • Number of events 6 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
|
Investigations
Urine ketone body
|
0.00%
0/71 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
5.7%
5/87 • Number of events 5 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
4.8%
4/84 • Number of events 4 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
|
Investigations
Urine White Blood Cells
|
0.00%
0/71 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
2.3%
2/87 • Number of events 2 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
6.0%
5/84 • Number of events 5 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
|
Nervous system disorders
Headache
|
0.00%
0/71 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
8.0%
7/87 • Number of events 10 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
10.7%
9/84 • Number of events 11 • Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days)
Adverse Events were assessed at each study visit, and from subject diary.
|
Additional Information
Dr. John McMichael
Beech Tree Labs, Inc.
Phone: 518-872-1144
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60