EsophagogastroduodenoscopyPhase 2NACSIMETNCT07245095
Premedication With N-acetylcysteine and Simethicone to Improve Mucosal Visualization in Elective Upper Endoscopy
A Phase 2 study testing Premedication with n-acetylcysteine and Premedication with simethicone in people with Esophagogastroduodenoscopy and Simethicone, run by Hospital General de Mexicali at 2 sites in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophagogastroduodenoscopy, Simethicone, N-Acetylcysteine
- What is being tested?
- Premedication with n-acetylcysteine and Premedication with simethicone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 2 sitesMexico
- Study dates
- 12 Sep 2025to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico2 sites, 2 recruiting
- Recruiting
Hospital Almater
Mexicali, Estado de Baja California, 21000
Jesus Alberto Camacho Escobedo, Gastroenterologist, 01 686 2146050, jesus13camacho@hotmail.com
- Recruiting
Hospital General de Mexicali
Mexicali, Estado de Baja California, 21100
Jesus Alberto Camacho Escobedo, Gastroenterologist, 55 686 2146050, jesus13camacho@hotmail.com
About this study
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
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:
Read more
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
Read the 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.
- Conditions
- Esophagogastroduodenoscopy, Simethicone, N-Acetylcysteine, Premedication, Visualization, Esophagogastroduodensocopy (EGD) Procedure
- Being tested
- Premedication with n-acetylcysteine, Placebo (drinking water), Premedication with simethicone
- Keywords
- Esophagogastroduodenoscopy, Mucous Membrane, Premedication, Simethicone, Acetylcysteine, Gastrointestinal Tract
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premedication with n-acetylcysteineDrug
Once the sample size has been calculated, patients who meet the inclusion criteria will be recruited. who will be randomized using the "Randomized for Clinical Trial" program for assignment to treatment groups A and B. Group A will receive 600 mg of N-acetylcysteine and 100 mg of simethicone orally 20 to 60 minutes before the procedure, while the control group will receive an equivalent placebo infusion (composed of drinking water). Premedication and placebo will be labeled in containers as medication or placebo by external personnel not involved in the study, and the identification of each bag will be noted on a sheet and kept in an envelope that will be opened at the end of the study. Tolerance will be evaluated. If any adverse events are identified, the principal investigator will be notified for action regarding the management of the adverse event and its reporting.
Placebo (drinking water)Drug
The control group will receive an equivalent placebo infusion (composed of drinking water)
Premedication with simethiconeDrug
Once the sample size has been calculated, patients who meet the inclusion criteria will be recruited. who will be randomized using the "Randomized for Clinical Trial" program for assignment to treatment groups A and B. Group A will receive 600 mg of N-acetylcysteine and 100 mg of simethicone orally 20 to 60 minutes before the procedure, while the control group will receive an equivalent placebo infusion (composed of drinking water). Premedication and placebo will be labeled in containers as medication or placebo by external personnel not involved in the study, and the identification of each bag will be noted on a sheet and kept in an envelope that will be opened at the end of the study. Tolerance will be evaluated. If any adverse events are identified, the principal investigator will be notified for action regarding the management of the adverse event and its reporting
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving n-acetylcysteine/simethicone | Active comparator | Not described Receives: Drug: Premedication with n-acetylcysteine; Drug: Premedication with simethicone |
| Patients receiving placebo | Placebo comparator | Not described Receives: Drug: Placebo (drinking water) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score on the Toronto Upper Gastrointestinal Cleaning Score (TUGCS)
The Toronto Upper Gastrointestinal Cleaning Score (TUGCS) is a validated scale that assesses mucosal cleanliness/visualization across four upper GI areas (fundus, body, antrum, and duodenum). Each area is scored from 0 to 3 (0 = poorest visualization; 3 = entire mucosa visible without suctioning/washing). The total score is the sum of all four areas (range 0-12). Higher scores indicate better mucosal cleanliness/visibility. Scoring is performed by blinded assessors during the procedure using standardized criteria.
Measured: During the index upper endoscopy (Day 0), scored intra-procedure (≈20-60 minutes after premedication).
Secondary outcomes (5)
Detection of Mucosal Lesions
Number of patients in whom mucosal lesions are detected during the procedure.
Measured: During endoscopy procedure
Complete Esophageal Visualization
Binary assessment (Yes/No) of whether complete esophageal visualization was achieved.
Measured: During endoscopy.
Histological gastritis according to the Updated Sydney System (0-3 per item) and OLGA/OLGIM staging (0-IV)
Measurement tool: Updated Sydney System (sum of domains not mandatory).
Sites and technique: 5 gastric biopsies according to the Sydney protocol (2 antrum, 2 body, 1 incisura angularis), fixed in formalin; H\&E and Giemsa staining (or IHC if necessary for H. pylori).
Domains and ranges (each 0-3):
- pylori density: 0 = absent, 1 = mild, 2 = moderate, 3 = marked.
Chronic inflammation (mononuclear): 0-3.
Activity (neutrophils): 0-3.
Glandular atrophy: 0-3.
Intestinal metaplasia: 0-3. Minimum-maximum range per domain: 0-3; higher scores = worse histological severity.
Risk staging:
OLGA (0-IV) for atrophy, OLGIM (0-IV) for intestinal metaplasia; higher stages = worse stage/higher risk.
Reported measure: distribution of scores per domain (0-3) and proportion per OLGA/OLGIM stage (0-IV), comparing arms.
Measured: Biopsies obtained during the index endoscopy (Day 0); histopathological report within 14 days
Presence and density of Helicobacter pylori by histology (Updated Sydney System 0-3)
Measurement tool: Updated Sydney System for H. pylori.
Range and direction: 0-3 (0 = not detected; 1 = mild; 2 = moderate; 3 = marked). Higher scores = higher bacterial density.
Technique: H\&E + Giemsa staining (or IHC if indeterminate).
Reported measure:
Proportion of patients positive for H. pylori (≥1 on the scale), and
Distribution of categories 0-3 per arm.
Measured: Biopsies obtained during the index endoscopy (Day 0); report within 14 days
Number of histologically confirmed neoplasic lesions per patient
Higher values reflect higher detection performance; this should be interpreted in conjunction with the detection rate (NDR)
Measured: During the index endoscopy (Day 0) and histological confirmation up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start12 Sep 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for EsophagogastroduodenoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General de Mexicali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245095
- Sponsor's protocol ID
- NACSIMET-ETDA-MEX2025
- Acronym
- NACSIMET
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data related to baseline demographics, Toronto Upper Gastrointestinal Cleaning Score (TUGS), endoscopic findings, and histopathological results.
Publications
Devereaux BM, Taylor ACF, Athan E, Wallis DJ, Brown RR, Greig SM, Bailey FK, Vickery K, Wardle E, Jones DM. Simethicone use during gastrointestinal endoscopy: Position statement of the Gastroenterological Society of Australia. J Gastroenterol Hepatol. 2019 Dec;34(12):2086-2089. doi: 10.1111/jgh.14757. Epub 2019 Jul 28.
PubMed 31242327Manfredi G, Berte R, Iiritano E, Alicante S, Londoni C, Brambilla G, Romeo S, Menozzi F, Griffanti P, Brandi G, Moreschi O, Pezzilli R, Zullo A, Buscarini E. Premedication with simethicone and N-acetylcysteine for improving mucosal visibility during upper gastrointestinal endoscopy in a Western population. Endosc Int Open. 2021 Feb;9(2):E190-E194. doi: 10.1055/a-1315-0114. Epub 2021 Jan 25.
PubMed 33532557Monrroy H, Vargas JI, Glasinovic E, Candia R, Azua E, Galvez C, Rojas C, Cabrera N, Vidaurre J, Alvarez N, Gonzalez J, Espino A, Gonzalez R, Parra-Blanco A. Use of N-acetylcysteine plus simethicone to improve mucosal visibility during upper GI endoscopy: a double-blind, randomized controlled trial. Gastrointest Endosc. 2018 Apr;87(4):986-993. doi: 10.1016/j.gie.2017.10.005. Epub 2017 Oct 14.
PubMed 29037773Beaufort IN, Verbeek RE, Bosman JH, Al-Toma A, Bogte A, Alvarez Herrero L, Weusten BLAM. Optimal timing of simethicone administration prior to upper endoscopy: A multicenter, single-blind, randomized controlled trial. Endosc Int Open. 2023 Oct 17;11(10):E992-E1000. doi: 10.1055/a-2157-5034. eCollection 2023 Oct.
PubMed 37854124Mahawongkajit P, Kanlerd A. A prospective randomized controlled trial comparing simethicone, N-acetylcysteine, sodium bicarbonate and peppermint for visualization in upper gastrointestinal endoscopy. Surg Endosc. 2021 Jan;35(1):303-308. doi: 10.1007/s00464-020-07397-8. Epub 2020 Feb 3.
PubMed 32016519Chang WK, Yeh MK, Hsu HC, Chen HW, Hu MK. Efficacy of simethicone and N-acetylcysteine as premedication in improving visibility during upper endoscopy. J Gastroenterol Hepatol. 2014 Apr;29(4):769-74. doi: 10.1111/jgh.12487.
PubMed 24325147Sajid MS, Rehman S, Chedgy F, Singh KK. Improving the mucosal visualization at gastroscopy: a systematic review and meta-analysis of randomized, controlled trials reporting the role of Simethicone +/- N-acetylcysteine. Transl Gastroenterol Hepatol. 2018 May 19;3:29. doi: 10.21037/tgh.2018.05.02. eCollection 2018.
PubMed 29971260Li Y, Du F, Fu D. The effect of using simethicone with or without N-acetylcysteine before gastroscopy: A meta-analysis and systemic review. Saudi J Gastroenterol. 2019 Jul-Aug;25(4):218-228. doi: 10.4103/sjg.SJG_538_18.
PubMed 31044749
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07245095
- Acronym / sponsor ID
- NACSIMET / NACSIMET-ETDA-MEX2025
- Conditions
- Esophagogastroduodenoscopy, Simethicone, N-Acetylcysteine, Premedication, Visualization, Esophagogastroduodensocopy (EGD) Procedure
- Keywords
- Esophagogastroduodenoscopy, Mucous Membrane, Premedication, Simethicone, Acetylcysteine, Gastrointestinal Tract
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Hospital General de MexicaliUniversity, hospital or other
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients receiving n-acetylcysteine/simethicone | Active comparator | Drug: Premedication with n-acetylcysteine, Drug: Premedication with simethicone |
| Patients receiving placebo | Placebo comparator | Drug: Placebo (drinking water) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Premedication with n-acetylcysteineOnce the sample size has been calculated, patients who meet the inclusion criteria will be recruited. who will be randomized using the "Randomized for Clinical Trial" program for assignment to treatment groups A and B. Group A will receive 600 mg of N-acetylcysteine and 100 mg of simethicone orally 20 to 60 minutes before the procedure, while the control group will receive an equivalent placebo infusion (composed of drinking water). Premedication and placebo will be labeled in containers as medication or placebo by external personnel not involved in the study, and the identification of each bag will be noted on a sheet and kept in an envelope that will be opened at the end of the study. Tolerance will be evaluated. If any adverse events are identified, the principal investigator will be notified for action regarding the management of the adverse event and its reporting. | Drug | Patients receiving n-acetylcysteine/simethicone |
| Placebo (drinking water)The control group will receive an equivalent placebo infusion (composed of drinking water) | Drug | Patients receiving placebo |
| Premedication with simethiconeOnce the sample size has been calculated, patients who meet the inclusion criteria will be recruited. who will be randomized using the "Randomized for Clinical Trial" program for assignment to treatment groups A and B. Group A will receive 600 mg of N-acetylcysteine and 100 mg of simethicone orally 20 to 60 minutes before the procedure, while the control group will receive an equivalent placebo infusion (composed of drinking water). Premedication and placebo will be labeled in containers as medication or placebo by external personnel not involved in the study, and the identification of each bag will be noted on a sheet and kept in an envelope that will be opened at the end of the study. Tolerance will be evaluated. If any adverse events are identified, the principal investigator will be notified for action regarding the management of the adverse event and its reporting | Drug | Patients receiving n-acetylcysteine/simethicone |
Primary outcome
Total score on the Toronto Upper Gastrointestinal Cleaning Score (TUGCS)
Time frame: During the index upper endoscopy (Day 0), scored intra-procedure (≈20-60 minutes after premedication).
The Toronto Upper Gastrointestinal Cleaning Score (TUGCS) is a validated scale that assesses mucosal cleanliness/visualization across four upper GI areas (fundus, body, antrum, and duodenum). Each area is scored from 0 to 3 (0 = poorest visualization; 3 = entire mucosa visible without suctioning/washing). The total score is the sum of all four areas (range 0-12). Higher scores indicate better mucosal cleanliness/visibility. Scoring is performed by blinded assessors during the procedure using standardized criteria.
5 secondary outcomes
Detection of Mucosal Lesions
Time frame: During endoscopy procedure
Complete Esophageal Visualization
Time frame: During endoscopy.
Histological gastritis according to the Updated Sydney System (0-3 per item) and OLGA/OLGIM staging (0-IV)
Time frame: Biopsies obtained during the index endoscopy (Day 0); histopathological report within 14 days
Presence and density of Helicobacter pylori by histology (Updated Sydney System 0-3)
Time frame: Biopsies obtained during the index endoscopy (Day 0); report within 14 days
Number of histologically confirmed neoplasic lesions per patient
Time frame: During the index endoscopy (Day 0) and histological confirmation up to 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Background: PubMed 31242327Devereaux BM, Taylor ACF, Athan E, Wallis DJ, Brown RR, Greig SM, Bailey FK, Vickery K, Wardle E, Jones DM. Simethicone use during gastrointestinal endoscopy: Position statement of the Gastroenterological Society of Australia. J Gastroenterol Hepatol. 2019 Dec;34(12):2086-2089. doi: 10.1111/jgh.14757. Epub 2019 Jul 28.
- Background: PubMed 33532557Manfredi G, Berte R, Iiritano E, Alicante S, Londoni C, Brambilla G, Romeo S, Menozzi F, Griffanti P, Brandi G, Moreschi O, Pezzilli R, Zullo A, Buscarini E. Premedication with simethicone and N-acetylcysteine for improving mucosal visibility during upper gastrointestinal endoscopy in a Western population. Endosc Int Open. 2021 Feb;9(2):E190-E194. doi: 10.1055/a-1315-0114. Epub 2021 Jan 25.
- Background: PubMed 29037773Monrroy H, Vargas JI, Glasinovic E, Candia R, Azua E, Galvez C, Rojas C, Cabrera N, Vidaurre J, Alvarez N, Gonzalez J, Espino A, Gonzalez R, Parra-Blanco A. Use of N-acetylcysteine plus simethicone to improve mucosal visibility during upper GI endoscopy: a double-blind, randomized controlled trial. Gastrointest Endosc. 2018 Apr;87(4):986-993. doi: 10.1016/j.gie.2017.10.005. Epub 2017 Oct 14.
- Background: PubMed 37854124Beaufort IN, Verbeek RE, Bosman JH, Al-Toma A, Bogte A, Alvarez Herrero L, Weusten BLAM. Optimal timing of simethicone administration prior to upper endoscopy: A multicenter, single-blind, randomized controlled trial. Endosc Int Open. 2023 Oct 17;11(10):E992-E1000. doi: 10.1055/a-2157-5034. eCollection 2023 Oct.
- Results publication: PubMed 32016519Mahawongkajit P, Kanlerd A. A prospective randomized controlled trial comparing simethicone, N-acetylcysteine, sodium bicarbonate and peppermint for visualization in upper gastrointestinal endoscopy. Surg Endosc. 2021 Jan;35(1):303-308. doi: 10.1007/s00464-020-07397-8. Epub 2020 Feb 3.
- Results publication: PubMed 24325147Chang WK, Yeh MK, Hsu HC, Chen HW, Hu MK. Efficacy of simethicone and N-acetylcysteine as premedication in improving visibility during upper endoscopy. J Gastroenterol Hepatol. 2014 Apr;29(4):769-74. doi: 10.1111/jgh.12487.
- Results publication: PubMed 29971260Sajid MS, Rehman S, Chedgy F, Singh KK. Improving the mucosal visualization at gastroscopy: a systematic review and meta-analysis of randomized, controlled trials reporting the role of Simethicone +/- N-acetylcysteine. Transl Gastroenterol Hepatol. 2018 May 19;3:29. doi: 10.21037/tgh.2018.05.02. eCollection 2018.
- Results publication: PubMed 31044749Li Y, Du F, Fu D. The effect of using simethicone with or without N-acetylcysteine before gastroscopy: A meta-analysis and systemic review. Saudi J Gastroenterol. 2019 Jul-Aug;25(4):218-228. doi: 10.4103/sjg.SJG_538_18.
- Individual participant dataSharing planned: Yes. De-identified individual participant data related to baseline demographics, Toronto Upper Gastrointestinal Cleaning Score (TUGS), endoscopic findings, and histopathological results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Premedication with n-acetylcysteine and Premedication with simethicone in people with Esophagogastroduodenoscopy and Simethicone, run by Hospital General de Mexicali at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis Andre Sanchez Perez, Resident (+ 52 6863468689, sanchez.luis3@uabc.edu.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total score on the Toronto Upper Gastrointestinal Cleaning Score (TUGCS) (time frame: During the index upper endoscopy (Day 0), scored intra-procedure (≈20-60 minutes after premedication).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07245095, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.