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ARTICAINE HYDROCHLORIDE

Clinical trials investigating ARTICAINE HYDROCHLORIDE are studying its use in people with Sjögren’s syndrome. These trials mainly look at clinical research goals such as tissue changes and how they relate to patient assessments. The available trial is an interventional Phase 2 study with a small group of participants.

Table of Contents

Trial overview

The available trial for ARTICAINE HYDROCHLORIDE is NCT05124925, a completed study in people with Sjögren’s syndrome.[1] The study title says it was designed to understand changes in salivary gland tissue and explore how those changes relate to clinical assessments.[1]

The trial data lists ARTICAINE, COMBINATIONS as one of the study interventions, alongside other drugs in the same study record.[1] The source data does not provide more detail on the role of ARTICAINE HYDROCHLORIDE within the full treatment plan.[1]

Study design and phase

This was an interventional study, which means researchers gave study treatments and then measured the results.[1] It was a Phase 2 trial, a stage that usually focuses on early testing of whether a treatment has the expected effect in a smaller group of people.[1]

The trial was completed and enrolled 20 participants.[1] Because the study was small, its findings are meant to help researchers learn more about the treatment and the disease, not to give a final answer for all patients.[1]

Participants and target population

The target population in this trial was people with Sjögren’s syndrome.[1] The source data does not list extra entry rules such as age range, sex, or disease severity.[1]

The study record only shows the total enrollment number, which was 20 participants.[1] This means the trial was focused on a small patient group, likely to look closely at tissue and clinical changes.[1]

Main outcomes being measured

The primary outcome was the change from baseline in logarithm of salivary gland B/B+T cell ratio at Week 25 (end of treatment).[1] In simple terms, the researchers measured how immune cells in the salivary gland changed over time compared with the start of the study.[1]

This outcome is a form of histopathology, which means studying tissue under a microscope.[1] The study title also says the researchers wanted to explore relationships with clinical assessments, meaning they wanted to see whether tissue changes matched changes seen during patient checks.[1]

What the study aimed to learn

The brief summary says the study was designed to investigate changes in salivary gland histopathology after treatment with ianalumab.[1] That means the main goal was to see whether treatment was linked to changes in gland tissue, not just symptom reports.[1]

For patients, this kind of trial helps researchers connect what they see in tissue samples with what happens in the clinic.[1] The available record does not report detailed results, so the main value of the source data is in showing the study question, phase, population, and main measurement.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05124925 Phase 2 Sjögren’s syndrome Completed 20

FAQ

  • What clinical trial is listed for ARTICAINE HYDROCHLORIDE? The listed study is a Phase 2 interventional trial in people with Sjögren's syndrome. It includes ARTICAINE, COMBINATIONS as one of several study drugs.
  • What condition is being studied? The trial is studying Sjögren's syndrome. This is the only condition named in the trial data.
  • Who can take part in the trial? The trial involved 20 participants. The source data does not give more details about age, sex, or other entry rules.
  • What is the trial trying to measure? The main outcome is the change in the salivary gland B/B+T cell ratio at Week 25. This measures changes in immune cells inside salivary gland tissue.
  • What phase is the study? The study is Phase 2. Phase 2 trials usually look more closely at whether a treatment has the expected effect in a small group of people.

Ongoing Clinical Trials on ARTICAINE HYDROCHLORIDE

  • Study on the Effects of Ianalumab in Patients with Sjögren’s Syndrome

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Sjögren's syndrome: A disease in which the immune system affects glands that make moisture, often causing dry eyes and dry mouth.
  • Interventional study: A type of clinical trial where participants receive one or more treatments or procedures so researchers can study the results.
  • Phase 2: A mid-stage trial that looks more closely at whether a treatment may work and what changes it causes in the body.
  • Enrollment: The number of people who joined the study.
  • Primary outcome: The main result the researchers plan to measure to answer the study question.
  • Salivary gland: A gland in the mouth that makes saliva, which helps keep the mouth moist.
  • Histopathology: The study of tissue under a microscope to look for disease-related changes.
  • B/B+T cell ratio: A measure comparing certain immune cells in tissue. It helps researchers see how the immune system is changing.
  • Week 25 (EOT): The 25th week of the study, with EOT meaning 'end of treatment.'
  • Clinical assessment: A medical check or measure used to see how a patient is doing in the study.

References