Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-26 @ 10:18 AM
Study NCT ID:
NCT07245095
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Premedication With N-acetylcysteine and Simethicone to Improve Mucosal Visualization in Elective Upper Endoscopy
Sponsor:
Hospital General de Mexicali
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NACSIMET
Brief 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
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
Detailed Description:
This is a randomized, double-blind, placebo-controlled, multicenter clinical trial designed to evaluate the efficacy of N-acetylcysteine (NAC) combined with simethicone in improving mucosal visibility during upper gastrointestinal endoscopy (UGIE). The evaluation will be based on the Toronto Upper Gastrointestinal Cleanliness Score (TUGS), a validated tool to assess mucosal cleanliness.
Participants will include adult patients aged 18 to 99 years who are scheduled to undergo diagnostic UGIE for various indications and who do not present with active gastrointestinal bleeding. Eligible participants will be randomized to receive either a single dose of NAC (600 mg) plus simethicone (100 mg) or a placebo (water), administered orally 20 to 60 minutes prior to the procedure. The allocation will be blinded to both participants and endoscopists.
The main objective of the study is to determine whether this premedication protocol results in better mucosal visibility, as measured by the total TUGS score. Secondary objectives include documenting the presence of significant endoscopic findings and histopathological diagnoses, and evaluating the tolerability and safety profile of the premedication.
TUGS scores will be assigned by trained endoscopists blinded to the treatment allocation. Variables such as age, sex, BMI, duration of fasting, hospital site, and endoscope model will be recorded and controlled for in statistical analyses. The study will also assess any potential adverse events associated with the administration of NAC/simethicone.
This study is categorized as Phase 2 because it evaluates the preliminary efficacy and short-term safety of pre-procedural oral N-acetylcysteine (NAC) and simethicone to improve mucosal visibility during diagnostic upper gastrointestinal endoscopy, using the Toronto Upper Gastrointestinal Cleaning Score (TUGCS) as a validated surrogate endpoint. Both agents have established safety profiles for other indications, but their combined use for this indication is not an approved or established standard of care. The trial is randomized, double-blind, placebo-controlled with a moderate sample size designed to estimate effect size and variability rather than to deliver definitive, multi-center confirmatory evidence on hard clinical outcomes.
All procedures will adhere to ethical standards, and informed consent will be obtained from all participants. Data will be collected in a coded, anonymized format and analyzed using appropriate statistical methods, including ANCOVA and non-parametric tests where assumptions of normality are not met.
Participants will include adult patients aged 18 to 99 years who are scheduled to undergo diagnostic UGIE for various indications and who do not present with active gastrointestinal bleeding. Eligible participants will be randomized to receive either a single dose of NAC (600 mg) plus simethicone (100 mg) or a placebo (water), administered orally 20 to 60 minutes prior to the procedure. The allocation will be blinded to both participants and endoscopists.
The main objective of the study is to determine whether this premedication protocol results in better mucosal visibility, as measured by the total TUGS score. Secondary objectives include documenting the presence of significant endoscopic findings and histopathological diagnoses, and evaluating the tolerability and safety profile of the premedication.
TUGS scores will be assigned by trained endoscopists blinded to the treatment allocation. Variables such as age, sex, BMI, duration of fasting, hospital site, and endoscope model will be recorded and controlled for in statistical analyses. The study will also assess any potential adverse events associated with the administration of NAC/simethicone.
This study is categorized as Phase 2 because it evaluates the preliminary efficacy and short-term safety of pre-procedural oral N-acetylcysteine (NAC) and simethicone to improve mucosal visibility during diagnostic upper gastrointestinal endoscopy, using the Toronto Upper Gastrointestinal Cleaning Score (TUGCS) as a validated surrogate endpoint. Both agents have established safety profiles for other indications, but their combined use for this indication is not an approved or established standard of care. The trial is randomized, double-blind, placebo-controlled with a moderate sample size designed to estimate effect size and variability rather than to deliver definitive, multi-center confirmatory evidence on hard clinical outcomes.
All procedures will adhere to ethical standards, and informed consent will be obtained from all participants. Data will be collected in a coded, anonymized format and analyzed using appropriate statistical methods, including ANCOVA and non-parametric tests where assumptions of normality are not met.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: