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NCT05098938 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare Sitavig (Acyclovir) Buccal Tablet With a Placebo in the Treatment of Herpes Labialis in Participants Whose Immune System Works Normally
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,020
- Enrollment target
NCT05098938 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 2,020 participants.
The verdict
NCT05098938, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,020 participants
- Enrollment target
Study Summary
Researchers are looking for a better way to treat people who have recurrent herpes labialis, also known as cold sores. This is a type of viral infection that causes redness and blisters on the mouth and lip and that recurs. Herpes labialis is caused by a virus called the herpes simplex virus (HSV). The infection is spread when a person comes into direct contact with someone else who has the infection. Once a person becomes infected with HSV, the virus multiplies and spreads, which can cause redness and blistering on the mouth and lip. The blisters crust over and heal. Once healed, the virus is said to go into an "inactive" phase. This means the virus does not cause any symptoms, but still remains in the body. HSV can then become "active" again. This means causing cold sore lesions to reappear. HSV can become active in different ways. Some of these include when a person has a fever, comes into contact with strong sunlight or has a condition that lowers one's immune system It can also happen during a woman's menstrual cycle, also called a period. In this study, the researchers want to gather additional data on acyclovir 50 mg tablet, an available treatment for herpes labialis. It is a buccal tablet that sticks to the gum inside the mouth and directly treats the infected area to help stop the HSV from multiplying and spreading. In this study, the researchers want to compare the efficacy of acyclovir 50 mg buccal tablets versus placebo in the treatment of herpes labialis. A placebo is a treatment that looks like the study medicine but does not have any medicine in it. Study participants will include those who have had at least 4 episodes of herpes labialis within the past 12 months prior to joining the study. To compare the study treatments, the researchers will measure the "duration of episode" (DOE) for each participant. DOE is amount of time it takes for symptoms to disappear and for herpes labialis lesions to heal after taking the study treatment. A doctor will l
Interventions
- DRUG Placebo
- DRUG Acyclovir 50mg buccal/topical tablet, BAYM008894/UI1614773
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,020 participants |
| Start Date | 2021-11-23 |
| Est. Completion | 2024-07-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05098938
The ClinicalTrials.gov registry entry for NCT05098938 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,020 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05098938 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05098938 about?
NCT05098938 is a clinical study titled "A Study to Compare Sitavig (Acyclovir) Buccal Tablet With a Placebo in the Treatment of Herpes Labialis in Participants Whose Immune System Works Normally". Researchers are looking for a better way to treat people who have recurrent herpes labialis, also known as cold sores. This is a type of viral infection that causes redness and blisters on the mouth and lip and that recurs. Herpes labialis is caused by a virus called the herpes simplex virus (HSV)....
What is the current status of trial NCT05098938?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,020 participants. The study started on 2021-11-23. Estimated completion is 2024-07-02.
What interventions are being tested in trial NCT05098938?
The interventions under investigation include: Placebo (DRUG), Acyclovir 50mg buccal/topical tablet, BAYM008894/UI1614773 (DRUG).
Who is sponsoring clinical trial NCT05098938?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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