New treatment option for Esophagogastroduodenoscopy
Official title Premedication With N-acetylcysteine and Simethicone to Improve Mucosal Visualization in Elective Upper Endoscopy
ClinicalTrials.gov ID: NCT07245095
What this study is testing
What is Premedication with n-acetylcysteine?
Premedication with n-acetylcysteine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for esophagogastroduodenoscopy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this randomized, double-blind, placebo-controlled clinical trial is to assess whether the combination of N-acetylcysteine and simethicone improves mucosal visibility during upper gastrointestinal endoscopy in adults aged 18 to 99 years of both sexes, including both healthy individuals and those with non-bleeding gastrointestinal symptoms. The main questions this study aims to answer are: Does pre-endoscopy administration of N-acetylcysteine/simethicone improve mucosal visualization based on the Toronto Upper Gastrointestinal Cleanliness Score (TUGS)?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99. Healthy volunteers may be eligible.
You may be able to join if
- Men and women aged 18 to 70 years old.
- Patients who agree to participate in the clinical trial.
- Patients without active gastrointestinal bleeding.
- Signing of informed consent form.
You likely can't join if
- Patients with a history of hypersensitivity to N-acetylcysteine
- Patients with a history of hypersensitivity to simethicone
- Patients with a previous endoscopic diagnosis
- Patients with a history of gastric or bariatric surgery
- Patients with a history of motor disorders (e.g., scleroderma, diabetic gastroparesis)
- Patients taking medications that delay gastric emptying (GLP-1 analogues)
See the full eligibility criteria
- Men and women aged 18 to 70 years old.
- Patients who agree to participate in the clinical trial.
- Patients without active gastrointestinal bleeding.
- Signing of informed consent form.
- Patients with a history of hypersensitivity to N-acetylcysteine
- Patients with a history of hypersensitivity to simethicone
- Patients with a previous endoscopic diagnosis
- Patients with a history of gastric or bariatric surgery
- Patients with a history of motor disorders (e.g., scleroderma, diabetic gastroparesis)
- Patients taking medications that delay gastric emptying (GLP-1 analogues)
- Pregnant or breastfeeding patients
- Patients who do not agree to participate in the clinical trial
The study team makes the final eligibility decision.
Where it's taking place
- Mexicali, Estado de Baja California, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexicali, Estado de Baja California, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.