Premedication With N-acetylcysteine and Simethicone to Improve Mucosal Visualization in Elective … (NCT07245095) | Clinical Trial Compass
RecruitingPhase 2
Premedication With N-acetylcysteine and Simethicone to Improve Mucosal Visualization in Elective Upper Endoscopy
Mexico132 participantsStarted 2025-09-12
Plain-language summary
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)?
Is this combination safe and well tolerated in this patient population?
Researchers will compare patients receiving N-acetylcysteine (600 mg) and simethicone (100 mg) orally 20-60 minutes before the procedure with those receiving placebo (water) to determine if there is a significant improvement in TUGS scores.
Participants will:
Receive a single oral dose of either N-acetylcysteine/simethicone or placebo prior to endoscopy
Undergo a routine upper GI endoscopy
Have mucosal cleanliness evaluated using the TUGS scoring system
Be monitored for any adverse events or intolerance
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total score on the Toronto Upper Gastrointestinal Cleaning Score (TUGCS)
Timeframe: During the index upper endoscopy (Day 0), scored intra-procedure (≈20-60 minutes after premedication).