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A Randomized Double-Blind Control-Comparison Crossover Trial of Oral Glutamine to Suppress Frequently Recurrent Herpes Labialis

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ClinicalTrials.gov Identifier: NCT00913692
Recruitment Status : Terminated (Terminated due to slow recruitment.)
First Posted : June 4, 2009
Results First Posted : June 11, 2012
Last Update Posted : June 11, 2012
Sponsor:
Information provided by (Responsible Party):
Jeffrey Cohen, National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions Herpes Labialis
Herpes Simplex Virus
Interventions Drug: Glutamine
Drug: Glycine
Enrollment 11
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Glutamine (Study Agent) or Glycine (Placebo)
Hide Arm/Group Description 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.
Period Title: Screening (4 Months)
Started 11
Completed 2
Not Completed 9
Reason Not Completed
Physician Decision             3
Not eligible after screening phase.             6
Period Title: Treatment Phase 1 (5 Months)
Started 2
Completed 1
Not Completed 1
Reason Not Completed
Physician Decision             1
Period Title: Washout (2 Weeks)
Started 1
Completed 1
Not Completed 0
Period Title: Treatment Phase 2 (5 Months)
Started 1
Completed 1
Not Completed 0
Arm/Group Title Glutamine (Study Agent) or Glycine (Placebo)
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
38  (10.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
7
  63.6%
Male
4
  36.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Does Oral Glutamine Reduce the Number of Recurrences of Herpes Labialis, Diagnosed by Clinical and Microbiologic Criteria, in Healthy Participants With Frequently Recurrent Disease.
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glutamine (Study Agent) or Glycine (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Does Oral Glutamine Reduce the Number of Clinical Recurrences of Herpes Labialis With or Without PCR Confirmation?
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glutamine (Study Agent) or Glycine (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Does Oral Glutamine Reduce the Time to First Recurrence of Herpes Labialis Diagnosed by Clinical and Microbiologic Criteria or Diagnosed by Clinical Criteria With or Without PCR Confirmation?
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glutamine (Study Agent) or Glycine (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Does Oral Glutamine Reduce the Duration of Recurrences?
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glutamine (Study Agent) or Glycine (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Does Oral Glutamine Reduce the Area of Recurrent Lesions?
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glutamine (Study Agent) or Glycine (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Phase 1 Washout Treatment Phase 2
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Treatment Phase 1 Washout Treatment Phase 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Treatment Phase 1 Washout Treatment Phase 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/1 (0.00%)      0/1 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Phase 1 Washout Treatment Phase 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      1/1 (100.00%)      1/1 (100.00%)    
Ear and labyrinth disorders       
Ear pain  1  1/2 (50.00%)  3 0/1 (0.00%)  0 0/1 (0.00%)  0
Gastrointestinal disorders       
abdominal pain  1  1/2 (50.00%)  2 0/1 (0.00%)  0 0/1 (0.00%)  0
Oral dysaesthesia  1  1/2 (50.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0
General disorders       
Edema  1 [1]  0/2 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0
Infections and infestations       
Sinusitis  1  1/2 (50.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0
Laryngitis  1  1/2 (50.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0
Nasopharyngitis  1  1/2 (50.00%)  2 0/1 (0.00%)  0 0/1 (0.00%)  0
Rhinitis  1  1/2 (50.00%)  2 0/1 (0.00%)  0 0/1 (0.00%)  0
Investigations       
Hepatic enzyme increased  1 [2]  0/2 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1
Blood lactate dehydrogenase abnormal  2 [3]  1/2 (50.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0
Nervous system disorders       
Headache  1  1/2 (50.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0
Tension Headache  1  1/2 (50.00%)  2 0/1 (0.00%)  0 0/1 (0.00%)  0
Psychiatric disorders       
Insomnia  1  1/2 (50.00%)  2 0/1 (0.00%)  0 0/1 (0.00%)  0
Sleep Disorder  1 [4]  1/2 (50.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Sore throat  1  2/2 (100.00%)  2 0/1 (0.00%)  0 0/1 (0.00%)  0
Epistaxis  1  1/2 (50.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0
Rhinorrhea  1/2 (50.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
2
Term from vocabulary, NCI CTCAE table
[1]
pitting edema to bilateral lower legs and ankles
[2]
elevated AST
[3]
elevated LDH
[4]
bizarre dreams
The protocol was terminated early due to slow recruitment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeffrey I. Cohen, MD
Organization: National Institute of Allergy and Infectious Diseases, Laboratory of Infectious Diseases
Phone: (301) 496-5265
EMail: jcohen@niaid.nih.gov
Layout table for additonal information
Responsible Party: Jeffrey Cohen, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00913692    
Other Study ID Numbers: 090159
09-I-0159
First Submitted: June 3, 2009
First Posted: June 4, 2009
Results First Submitted: February 29, 2012
Results First Posted: June 11, 2012
Last Update Posted: June 11, 2012