NCT07245095RecruitingPhase 2
Premedication With N-acetylcysteine and Simethicone to Improve Mucosal Visualization in Elective Upper Endoscopy
Randomized Controlled Trial to Evaluate the Effect of Premedication With N-acetylcysteine and Simethicone on Mucosal Visibility During Elective Upper Gastrointestinal Endoscopy Using the TUGS Score
Source: ClinicalTrials.gov · Last updated 24 Nov 2025
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- First submitted
- 10 Sept 2025
- Start date
- 12 Sept 2025
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Hospital General de Mexicali
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07245095
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 132
- From 12 Sept 2025 to the primary completion date, 30 Nov 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a previous endoscopic diagnosis
- Patients taking medications that delay gastric emptying (GLP-1 analogues)
Other illness
- Patients with a history of hypersensitivity to N-acetylcysteine
- Patients with a history of hypersensitivity to simethicone
- Patients with a history of gastric or bariatric surgery
- Patients with a history of motor disorders (e.g., scleroderma, diabetic gastroparesis)
Other
- Pregnant or breastfeeding patients
- Patients who do not agree to participate in the clinical trial
Who the study is looking for
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital General de Mexicali Coordinator of this site? Confirm its status | Mexicali | Mexico | Recruiting |
| Hospital Almater Coordinator of this site? Confirm its status | Mexicali | Mexico | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.