Herpes LabialisPhase 2NCT00913692
A Randomized Double-Blind Control-Comparison Crossover Trial of Oral Glutamine to Suppress Frequently Recurrent Herpes Labialis
A Phase 2 study testing Glutamine and Glycine in people with Herpes Labialis and Herpes Simplex Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: A cold sore is usually a blistering rash on or near the lips, caused by infection with herpes simplex virus. After the first infection, the virus goes into a dormant (inactive) state, but it can continue to cause cold sores. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Herpes Labialis, Herpes Simplex Virus
- What is being tested?
- Glutamine and Glycine
- Type of treatment
- Pill or oral medicine
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Dec 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, ages 18 to 65, who report a history of 6 or more episodes of herpes labialis per year.
- Subject agrees to refrain from using over the counter (OTC), prescription or supplemental antiviral medications without obtaining permission from the study team during the course of the study.
- Women with child-bearing potential are required and willing to practice two effective methods of birth control beginning with the first treatment period and continuing until the end of the study.
- Women with child-bearing potential are required to have a negative pregnancy test at the time of enrollment and at the time of randomization.
- To be eligible for randomization in the treatment phase of the study, the participants must experience at least 2 clinically confirmed episodes of herpes labialis, 1 of which must be virologically confirmed, during the 4 month screening period.
Who cannot join
- Oral or intravenous antiviral therapy < 4 weeks before enrollment or during the study with the following agents is not permitted: acyclovir (intravenous), ganciclovir (intravenous or oral), valganiciclovir (oral), cidofovir (intravenous), or foscarnet (intravenous).
- Suppressive therapy with oral acyclovir, valacyclovir or famciclovir or with topical antivirals 4 weeks prior to enrollment or during the study is not permitted.
- Use of oral acyclovir or valacyclovir or famciclovir or topical antiviral ointments or creams for the treatment of herpes labialis outbreaks during the study is permitted AFTER the outbreak has been documented by the study team..
- Evidence of active herpes labialis reactivation at the time of enrollment. The volunteer can be enrolled after resolution of herpes labialis and if inclusion and exclusion criteria are still met.
- Subjects with conditions associated with immunodeficiency (e.g., human immunodeficiency virus infection) or conditions requiring either daily systemic corticosteroids exceeding a dose equivalent to10 mg/day of prednisone or other significant immunosuppressant therapy (e.g., organ or stem cell transplantation).
- Persons with significant liver or kidney disease [serum glutamic oxaloacetic transaminase [SGOT], serum glutamine pyruvic transaminase [SGPT], or alkaline phosphatase > 2.5 times the upper limit of normal (ULN), total bilirubin > 1.5 times the ULN, or serum creatinine > 1.5 times the ULN].
Show all 13Show fewer
- Persons with an active seizure disorder. For persons with prior history of seizures, the person should be seizure free for 5 years and not on any anti-seizure medication in order to be enrolled into the study. (Since glutamine is metabolized to glutamate and ammonia, and glutamate is the main excitatory neurotransmitter in the central nervous system (CNS), there is a theoretical increased risk of seizures).
- Women who are known to be pregnant (pregnancy category C) or breastfeeding (it is not known whether glutamine is excreted in human milk).
- History of allergic reaction to glutamine or glutamic acid or their derivatives (e.g., monosodium glutamate) or to glycine or sucralose.
- Subjects cannot take supplemental amino acids (e.g., glutamine, glycine, arginine, other amino acids) or high protein supplements, such as Boost within 30 days of enrollment into the study or during the study (except for study drug amino acid). Subjects can take vitamins.
- Persons treated with atypical neuroleptics such as clozapine (Clozaril, FazoCIo) or olanzapine (Zyprexa, Zydis).
- Participation in any study involving investigational drugs within 30 days prior to entry into this trial.
- Any condition (e.g., schizophrenia, psychosis, major depression, mental deficiency or illness) or major co-morbidity that the study investigator thinks might compromise the person's ability to comply with the requirements of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- A cold sore is usually a blistering rash on or near the lips, caused by infection with herpes simplex virus. After the first infection, the virus goes into a dormant (inactive) state, but it can continue to cause cold sores.
- Most people with the herpes simplex virus have a few episodes of cold sores per year. However, some individuals may have many recurrent episodes that are uncomfortable and may cause embarrassment. Researchers are attempting to find treatments that can decrease the number of cold sore episodes for people who have six or more episodes per year.
- Glutamine is a molecule called an amino acid and is one of the components that make up proteins in the body. Clinical studies using glutamine have addressed the potential of glutamine to improve immune function and to heal damaged tissue or to help healing.
Read more
Objectives:
- To find out if the dietary supplement glutamine can help individuals with frequently recurring (more than six episodes per year) cold sores.
Eligibility:
- Patients between 18 and 65 years of age who have a history of having six or more cold sore episodes per year, and have not received certain kinds of drug treatment for the cold sores within 1 month of beginning the study.
- Patients who have two or more episodes of cold sores caused by the herpes simplex virus will be eligible for treatment as part of this study.
Design:
- Initial clinical visit for a physical examination and medical history, at which blood samples will be drawn for testing.
- Eligible participants will undergo a 4-month screening period. Patients who develop sores during this period will visit the NIH to have the sore examined to determine if it is caused by the herpes virus. Patients who have two or more episodes of cold sores caused by the herpes simplex virus will be eligible for treatment.
- Patients who are eligible for treatment will provide an initial blood sample and will receive randomized doses of either glutamine or glycine (another amino acid), which must be taken on a regular schedule twice daily, mixed with either liquid or soft food. Patients who develop sores during this period will visit the NIH to have the sore examined to determine if it is caused by the herpes virus. Blood, urine, and saliva specimens will be collected each month during the treatment period. A 2-week washout period will occur between the 2 treatment periods when no doses of glutamine or glycine will be taken.
- Patients will then undergo a second 5-month treatment period with either glutamine or glycine (whichever was not given in the first part of the study), taken in the same manner as before. Patients who develop sores during this period will visit the NIH to have the sore examined to determine if it is caused by the herpes virus.
- After the second treatment, patients will remain in touch with researchers for 1 month to note any changes.
Read the detailed description
Frequently recurrent herpes simplex virus type 1 (HSV-1) infection of the lips or perioral area, known as herpes labialis, or commonly as cold sores, can cause discomfort, pain, and embarrassment. Traditional antiviral therapies are moderately effective in suppressing these recurrences. Studies have shown that the amino acid glutamine can affect HSV-1 reactivation in vitro. Glutamine has been studied in various clinical situations and has been found to decrease morbidity in critically ill patients (reducing nosocomial infections), in patients receiving chemotherapy or undergoing bone marrow transplantation (reducing severity of stomatitis, reducing incidence of infection, shortening hospital stay), and in patients with short gut syndrome (decreasing requirement for parenteral nutrition). No significant adverse consequences of glutamine therapy have been reported in these patients. We will conduct a randomized, double-blind, control-comparison crossover trial comparing the efficacy of glutamine versus glycine (control) to suppress recurrences of herpes labialis in patients with frequent episodes (greater than or equal to 6 per year). Based on our in vitro and in vivo data, we hypothesize that oral glutamine will decrease the number of recurrences of herpes labialis during a 5-month treatment period in participants with frequently recurring herpes labialis compared with control.
- Conditions
- Herpes Labialis, Herpes Simplex Virus
- Being tested
- Glutamine, Glycine
- Keywords
- Glutamine, Herpes Labialis, Herpes Simplex Virus, Cold Sore
- Medical subject headings
- Herpes Labialis, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutamineDrug
Subjects were randomized to take one of the study agents, 15 gm by mouth twice daily for 5 months. After a 2 week washout period, subjects began the other agent at 15 gm by mouth twice daily for 5 months.
GlycineDrug
Subjects were randomized to take one of the study agents, 15 gm by mouth twice daily for 5 months. After a 2 week washout period, subjects began the other agent at 15 gm by mouth twice daily for 5 months.
What is being measured
The primary outcome is the main question the study is designed to answer.
Does Oral Glutamine Reduce the Number of Recurrences of Herpes Labialis, Diagnosed by Clinical and Microbiologic Criteria, in Healthy Participants With Frequently Recurrent Disease.
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.
Measured: 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.
Secondary outcomes (4)
Does Oral Glutamine Reduce the Number of Clinical Recurrences of Herpes Labialis With or Without PCR Confirmation?
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.
Measured: 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.
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?
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.
Measured: 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.
Does Oral Glutamine Reduce the Duration of Recurrences?
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.
Measured: 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.
Does Oral Glutamine Reduce the Area of Recurrent Lesions?
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Terminated due to slow recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Herpes LabialisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Jeffrey Cohen, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913692
- Sponsor's protocol ID
- 090159
- Other IDs
- 09-I-0159
- Status last verified
- May 2012
- First submitted
- 3 Jun 2009
- Last updated
- 11 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Anderson PM, Ramsay NK, Shu XO, Rydholm N, Rogosheske J, Nicklow R, Weisdorf DJ, Skubitz KM. Effect of low-dose oral glutamine on painful stomatitis during bone marrow transplantation. Bone Marrow Transplant. 1998 Aug;22(4):339-44. doi: 10.1038/sj.bmt.1701317.
PubMed 9722068Aquino VM, Harvey AR, Garvin JH, Godder KT, Nieder ML, Adams RH, Jackson GB, Sandler ES. A double-blind randomized placebo-controlled study of oral glutamine in the prevention of mucositis in children undergoing hematopoietic stem cell transplantation: a pediatric blood and marrow transplant consortium study. Bone Marrow Transplant. 2005 Oct;36(7):611-6. doi: 10.1038/sj.bmt.1705084.
PubMed 16086046Baker D, Eisen D. Valacyclovir for prevention of recurrent herpes labialis: 2 double-blind, placebo-controlled studies. Cutis. 2003 Mar;71(3):239-42.
PubMed 12661753
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Control-Comparison Crossover Trial of Oral Glutamine to Suppress Frequently Recurrent Herpes Labialis
- ClinicalTrials.gov ID
- NCT00913692
- Acronym / sponsor ID
- 090159
- Conditions
- Herpes Labialis, Herpes Simplex Virus
- Keywords
- Glutamine, Herpes Labialis, Herpes Simplex Virus, Cold Sore
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to slow recruitment.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jun 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Posted 11 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- A cold sore is usually a blistering rash on or near the lips, caused by infection with herpes simplex virus. After the first infection, the virus goes into a dormant (inactive) state, but it can continue to cause cold sores.
- Most people with the herpes simplex virus have a few episodes of cold sores per year. However, some individuals may have many recurrent episodes that are uncomfortable and may cause embarrassment. Researchers are attempting to find treatments that can decrease the number of cold sore episodes for people who have six or more episodes per year.
- Glutamine is a molecule called an amino acid and is one of the components that make up proteins in the body. Clinical studies using glutamine have addressed the potential of glutamine to improve immune function and to heal damaged tissue or to help healing.
Objectives:
- To find out if the dietary supplement glutamine can help individuals with frequently recurring (more than six episodes per year) cold sores.
Eligibility:
- Patients between 18 and 65 years of age who have a history of having six or more cold sore episodes per year, and have not received certain kinds of drug treatment for the cold sores within 1 month of beginning the study.
- Patients who have two or more episodes of cold sores caused by the herpes simplex virus will be eligible for treatment as part of this study.
Design:
- Initial clinical visit for a physical examination and medical history, at which blood samples will be drawn for testing.
- Eligible participants will undergo a 4-month screening period. Patients who develop sores during this period will visit the NIH to have the sore examined to determine if it is caused by the herpes virus. Patients who have two or more episodes of cold sores caused by the herpes simplex virus will be eligible for treatment.
- Patients who are eligible for treatment will provide an initial blood sample and will receive randomized doses of either glutamine or glycine (another amino acid), which must be taken on a regular schedule twice daily, mixed with either liquid or soft food. Patients who develop sores during this period will visit the NIH to have the sore examined to determine if it is caused by the herpes virus. Blood, urine, and saliva specimens will be collected each month during the treatment period. A 2-week washout period will occur between the 2 treatment periods when no doses of glutamine or glycine will be taken.
- Patients will then undergo a second 5-month treatment period with either glutamine or glycine (whichever was not given in the first part of the study), taken in the same manner as before. Patients who develop sores during this period will visit the NIH to have the sore examined to determine if it is caused by the herpes virus.
- After the second treatment, patients will remain in touch with researchers for 1 month to note any changes.
Detailed description
Frequently recurrent herpes simplex virus type 1 (HSV-1) infection of the lips or perioral area, known as herpes labialis, or commonly as cold sores, can cause discomfort, pain, and embarrassment. Traditional antiviral therapies are moderately effective in suppressing these recurrences. Studies have shown that the amino acid glutamine can affect HSV-1 reactivation in vitro. Glutamine has been studied in various clinical situations and has been found to decrease morbidity in critically ill patients (reducing nosocomial infections), in patients receiving chemotherapy or undergoing bone marrow transplantation (reducing severity of stomatitis, reducing incidence of infection, shortening hospital stay), and in patients with short gut syndrome (decreasing requirement for parenteral nutrition). No significant adverse consequences of glutamine therapy have been reported in these patients. We will conduct a randomized, double-blind, control-comparison crossover trial comparing the efficacy of glutamine versus glycine (control) to suppress recurrences of herpes labialis in patients with frequent episodes (greater than or equal to 6 per year). Based on our in vitro and in vivo data, we hypothesize that oral glutamine will decrease the number of recurrences of herpes labialis during a 5-month treatment period in participants with frequently recurring herpes labialis compared with control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (13 listed)
- Oral or intravenous antiviral therapy < 4 weeks before enrollment or during the study with the following agents is not permitted: acyclovir (intravenous), ganciclovir (intravenous or oral), valganiciclovir (oral), cidofovir (intravenous), or foscarnet (intravenous).
- Evidence of active herpes labialis reactivation at the time of enrollment. The volunteer can be enrolled after resolution of herpes labialis and if inclusion and exclusion criteria are still met.
- Subjects with conditions associated with immunodeficiency (e.g., human immunodeficiency virus infection) or conditions requiring either daily systemic corticosteroids exceeding a dose equivalent to10 mg/day of prednisone or other significant immunosuppressant therapy (e.g., organ or stem cell transplantation).
- Persons with significant liver or kidney disease [serum glutamic oxaloacetic transaminase [SGOT], serum glutamine pyruvic transaminase [SGPT], or alkaline phosphatase > 2.5 times the upper limit of normal (ULN), total bilirubin > 1.5 times the ULN, or serum creatinine > 1.5 times the ULN].
- Persons with an active seizure disorder. For persons with prior history of seizures, the person should be seizure free for 5 years and not on any anti-seizure medication in order to be enrolled into the study. (Since glutamine is metabolized to glutamate and ammonia, and glutamate is the main excitatory neurotransmitter in the central nervous system (CNS), there is a theoretical increased risk of seizures).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlutamineSubjects were randomized to take one of the study agents, 15 gm by mouth twice daily for 5 months. After a 2 week washout period, subjects began the other agent at 15 gm by mouth twice daily for 5 months. | Drug | – |
| GlycineSubjects were randomized to take one of the study agents, 15 gm by mouth twice daily for 5 months. After a 2 week washout period, subjects began the other agent at 15 gm by mouth twice daily for 5 months. | Drug | – |
Primary outcome
Does Oral Glutamine Reduce the Number of Recurrences of Herpes Labialis, Diagnosed by Clinical and Microbiologic Criteria, in Healthy Participants With Frequently Recurrent Disease.
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.
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.
4 secondary outcomes
Does Oral Glutamine Reduce the Number of Clinical Recurrences of Herpes Labialis With or Without PCR Confirmation?
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.
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?
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.
Does Oral Glutamine Reduce the Duration of Recurrences?
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.
Does Oral Glutamine Reduce the Area of Recurrent Lesions?
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9722068Anderson PM, Ramsay NK, Shu XO, Rydholm N, Rogosheske J, Nicklow R, Weisdorf DJ, Skubitz KM. Effect of low-dose oral glutamine on painful stomatitis during bone marrow transplantation. Bone Marrow Transplant. 1998 Aug;22(4):339-44. doi: 10.1038/sj.bmt.1701317.
- Background: PubMed 16086046Aquino VM, Harvey AR, Garvin JH, Godder KT, Nieder ML, Adams RH, Jackson GB, Sandler ES. A double-blind randomized placebo-controlled study of oral glutamine in the prevention of mucositis in children undergoing hematopoietic stem cell transplantation: a pediatric blood and marrow transplant consortium study. Bone Marrow Transplant. 2005 Oct;36(7):611-6. doi: 10.1038/sj.bmt.1705084.
- Background: PubMed 12661753Baker D, Eisen D. Valacyclovir for prevention of recurrent herpes labialis: 2 double-blind, placebo-controlled studies. Cutis. 2003 Mar;71(3):239-42.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glutamine and Glycine in people with Herpes Labialis and Herpes Simplex Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Does Oral Glutamine Reduce the Number of Recurrences of Herpes Labialis, Diagnosed by Clinical and Microbiologic Criteria, in Healthy Participants With Frequently Recurrent Disease. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00913692, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2012.