Trial Outcomes & Findings for A Randomized Double-Blind Control-Comparison Crossover Trial of Oral Glutamine to Suppress Frequently Recurrent Herpes Labialis (NCT NCT00913692)
NCT ID: NCT00913692
Last Updated: 2012-06-11
Results Overview
During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of outbreaks would be measured during each phase.
TERMINATED
PHASE2
11 participants
The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.
2012-06-11
Participant Flow
Recruitment began in November 2009 at the NIH Clinical Center outpatient clinic. Eleven study participants were enrolled and screened from 11/2009 - 11/2010. Two of these participants proceeded to the treatment phase of the study.
Participants were enrolled and randomized to the treatment phase only if they met the eligibility criteria after completing the 4 month screening phase. After completion of phase 1 of treatment, there was a 2 week wash out period before beginning phase 2 of treatment.
Participant milestones
| Measure |
Glutamine (Study Agent) or Glycine (Placebo)
Participants were enrolled and monitored to document presence of 2 clinically confirmed episodes of herpes labialis, 1 of which must be virologically confirmed, during the screening period. Participants took 15 gm of study agent or placebo by mouth twice daily for 5 months followed by a 2 week wash-out. Then participants took the other agent for another 5 months.
|
|---|---|
|
Screening (4 Months)
STARTED
|
11
|
|
Screening (4 Months)
COMPLETED
|
2
|
|
Screening (4 Months)
NOT COMPLETED
|
9
|
|
Treatment Phase 1 (5 Months)
STARTED
|
2
|
|
Treatment Phase 1 (5 Months)
COMPLETED
|
1
|
|
Treatment Phase 1 (5 Months)
NOT COMPLETED
|
1
|
|
Washout (2 Weeks)
STARTED
|
1
|
|
Washout (2 Weeks)
COMPLETED
|
1
|
|
Washout (2 Weeks)
NOT COMPLETED
|
0
|
|
Treatment Phase 2 (5 Months)
STARTED
|
1
|
|
Treatment Phase 2 (5 Months)
COMPLETED
|
1
|
|
Treatment Phase 2 (5 Months)
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Glutamine (Study Agent) or Glycine (Placebo)
Participants were enrolled and monitored to document presence of 2 clinically confirmed episodes of herpes labialis, 1 of which must be virologically confirmed, during the screening period. Participants took 15 gm of study agent or placebo by mouth twice daily for 5 months followed by a 2 week wash-out. Then participants took the other agent for another 5 months.
|
|---|---|
|
Screening (4 Months)
Physician Decision
|
3
|
|
Screening (4 Months)
Not eligible after screening phase.
|
6
|
|
Treatment Phase 1 (5 Months)
Physician Decision
|
1
|
Baseline Characteristics
A Randomized Double-Blind Control-Comparison Crossover Trial of Oral Glutamine to Suppress Frequently Recurrent Herpes Labialis
Baseline characteristics by cohort
| Measure |
Glutamine (Study Agent) or Glycine (Placebo)
n=11 Participants
Participants were enrolled and monitored to document presence of 2 clinically confirmed episodes of herpes labialis, 1 of which must be virologically confirmed, during the screening period. Participants took 15 gm of study agent or placebo by mouth twice daily for 5 months followed by a 2 week wash-out. Then participants took the other agent for another 5 months.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
38 years
STANDARD_DEVIATION 10.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.Population: One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the primary outcome could not be measured and analyzed.
During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of outbreaks would be measured during each phase.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.Population: One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.
During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of recurrences would be documented during each phase of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.Population: One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.
During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of recurrences and start and end dates of each recurrence would be documented during each phase of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.Population: One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.
During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of recurrences and start and end dates of each recurrence would be documented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.Population: One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.
During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of recurrences, start and end dates of each recurrence and measurement of each lesion during each phase of the study would be documented.
Outcome measures
Outcome data not reported
Adverse Events
Treatment Phase 1
Washout
Treatment Phase 2
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Phase 1
n=2 participants at risk
2 participants were eligible for the treatment phase of the study after the screening period. 1 participant completed treatment phase 1 \& 2. 1 participant was withdrawn from treatment phase 1 after the investigator decided to place the study on hold.
|
Washout
n=1 participants at risk
2 participants were eligible for the treatment phase of the study after the screening period. 1 participant completed treatment phase 1 \& 2. 1 participant was withdrawn from treatment phase 1 after the investigator decided to place the study on hold.
|
Treatment Phase 2
n=1 participants at risk
2 participants were eligible for the treatment phase of the study after the screening period. 1 participant completed treatment phase 1 \& 2. 1 participant was withdrawn from treatment phase 1 after the investigator decided to place the study on hold.
|
|---|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
50.0%
1/2 • Number of events 2 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
|
Ear and labyrinth disorders
Ear pain
|
50.0%
1/2 • Number of events 3 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
50.0%
1/2 • Number of events 1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
|
General disorders
Edema
|
0.00%
0/2 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
100.0%
1/1 • Number of events 1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
|
Infections and infestations
Sinusitis
|
50.0%
1/2 • Number of events 1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
|
Infections and infestations
Laryngitis
|
50.0%
1/2 • Number of events 1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
1/2 • Number of events 2 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
|
Infections and infestations
Rhinitis
|
50.0%
1/2 • Number of events 2 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/2 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
100.0%
1/1 • Number of events 1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
|
Investigations
Blood lactate dehydrogenase abnormal
|
50.0%
1/2 • Number of events 1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
|
Nervous system disorders
Tension Headache
|
50.0%
1/2 • Number of events 2 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
|
Psychiatric disorders
Insomnia
|
50.0%
1/2 • Number of events 2 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
|
Psychiatric disorders
Sleep Disorder
|
50.0%
1/2 • Number of events 1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
100.0%
2/2 • Number of events 2 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
50.0%
1/2 • Number of events 1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
50.0%
1/2 • Number of events 1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
0.00%
0/1 • From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
|
Additional Information
Jeffrey I. Cohen, MD
National Institute of Allergy and Infectious Diseases, Laboratory of Infectious Diseases
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place