Gastric Mucosal LesionPhase 4NCT02357303
Simethicone and N-acetylcysteine in Upper Endoscopy - Prospective Double-blinded Randomized Controlled Trial
A Phase 4 study testing Simethicone and Acetylcysteine in people with Gastric Mucosal Lesion, run by Portuguese Oncology Institute, Coimbra at 1 site in Portugal.
Trial summary
The upper endoscopy is one of the most common methods for the diagnosis and treatment of upper gastrointestinal (GI) tract diseases and provides a unique opportunity to identify early neoplastic lesions. Before an upper endoscopy it is required a 6 hour fasting period[1]. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gastric Mucosal Lesion
- What is being tested?
- Simethicone and Acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 sitePortugal
- Study dates
- Apr 2015to Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- consecutive series of patients scheduled for upper gastrointestinal endoscopy
- signed informed consent
Who cannot join
- sedation
- previous total gastrectomy
- known neoplasia or stenosis
- therapeutic or urgent procedures
- allergies to simethicone or N-acetylcysteine
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Portuguese Oncology Institute - Coimbra
Coimbra, Coimbra District, 3001-651
About this study
Official title: Premedication With Simethicone and N-acetylcysteine in Improving Mucosal Visibility During Upper Endoscopy - a Prospective Double-blinded Randomized Controlled Trial
The upper endoscopy is one of the most common methods for the diagnosis and treatment of upper gastrointestinal (GI) tract diseases and provides a unique opportunity to identify early neoplastic lesions.
Before an upper endoscopy it is required a 6 hour fasting period[1]. However, even with this fasting period, sometimes the mucosal visualization, especially in the stomach, is impaired by the presence of foam, bubbles or gastric mucus.
Read more
To improve visualization of the gastric mucosa, it is possible to administrate an oral solution of defoaming agents such as Simethicone and mucolytic agents like Pronase or N-Acetylcysteine previously to the procedure.
The aim of this project is to determine if the use of premedication with simethicone, alone or in association with N-Acetylcysteine, improves mucosal visualization during an upper GI endoscopy.
Read the detailed description
- Study type: prospective, randomized, double-blinded, placebo-controlled trial: i. Prospective inclusion of patients; ii. Randomization by computer generated tables; iii. Allocation concealment by sealed, opaque envelopes; iv. Double-blinded - nurse instructed not to reveal treatment; patient and doctor unaware of treatment;
- Patient selection: consecutive series of patients scheduled for upper gastrointestinal endoscopy; Exclusion criteria - sedation, previous total gastrectomy, known neoplasia or stenosis, allergies to simethicone or N-acetylcysteine, therapeutic or urgent procedures;
- Sample size: 270 (3 groups of 90 patients): to improve "excellent" preparations from 20% (value from our own database) to 40% and assuming a normal distribution and a power of 80% (α=0.05), the calculated sample size of each of the 3 groups was 82; allowing for a 10% dropout rate, the sample size is 90 (270 patients overall); Groups: Group A - 100mL of water (placebo); Group B - 100mL of water plus 100mg Simethicone; Group C - 100mL of water plus 100mg Simethicone plus 600mg N-acetylcysteine;
- Data collection methods: form sheet filled by nurses (appendix 1) and endoscopist (appendix 2);
- Analysed variables: patients characteristics (age, gender), indication for endoscopy, time from administration to procedure, score of mucosal visualization, side effects of medication;
- Statistical analysis: chi-square test.
- Conditions
- Gastric Mucosal Lesion
- Being tested
- Simethicone, Acetylcysteine, Placebo
- Keywords
- Randomized controlled trial, Endoscopy, Gastric mucosa, Simethicone, Acetylcysteine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimethiconeDrug
Also called Aero-OM
100mL of water plus 100mg Simethicone by mouth, 15 to 30 minutes before endoscopy
AcetylcysteineDrug
Also called Fluimucil
100mL of water plus 100mg Simethicone plus 600mg N-acetylcysteine by mouth, 15 to 30 minutes before endoscopy
PlaceboOther
100mL of water
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Group A - 100mL of water by mouth, 15 to 30 minutes before endoscopy Receives: Other: Placebo |
| Simethicone | Active comparator | Group B - 100mL of water plus 100mg Simethicone by mouth, 15 to 30 minutes before endoscopy Receives: Drug: Simethicone |
| Simethicone plus N-acetylcysteine | Active comparator | Group C - 100mL of water plus 100mg Simethicone plus 600mg N-acetylcysteine by mouth, 15 to 30 minutes before endoscopy Receives: Drug: Acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of mucosal visualization
Evaluation of the visibility of gastric mucosa during upper endoscopy using a scale (excelent, adequadate or inadequate) for esophagus, stomach and duodenum
Measured: 1 day (During endoscopy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Gastric Mucosal LesionStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portuguese Oncology Institute, Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luís André Caio Elvas, Portuguese Oncology Institute, Coimbra
- Investigators
- Luís Elvas, MD, Principal investigator, Gastroenterology Department, Portuguese Oncology Institute - Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357303
- Sponsor's protocol ID
- PortugueseOIC 001
- Status last verified
- Jan 2016
- First submitted
- 29 Jan 2015
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Faigel DO, Eisen GM, Baron TH, Dominitz JA, Goldstein JL, Hirota WK, Jacobson BC, Johanson JF, Leighton JA, Mallery JS, Raddawi HM, Vargo JJ 2nd, Waring JP, Fanelli RD, Wheeler-Harbough J; Standards of Practice Committee. American Society for Gastrointestinal Endoscopy. Preparation of patients for GI endoscopy. Gastrointest Endosc. 2003 Apr;57(4):446-50. doi: 10.1016/s0016-5107(03)80006-8. No abstract available.
PubMed 12665751Asl SM, Sivandzadeh GR. Efficacy of premedication with activated Dimethicone or N-acetylcysteine in improving visibility during upper endoscopy. World J Gastroenterol. 2011 Oct 7;17(37):4213-7. doi: 10.3748/wjg.v17.i37.4213.
PubMed 22072853Chen MJ, Wang HY, Chang CW, Hu KC, Hung CY, Chen CJ, Shih SC. The add-on N-acetylcysteine is more effective than dimethicone alone to eliminate mucus during narrow-band imaging endoscopy: a double-blind, randomized controlled trial. Scand J Gastroenterol. 2013 Feb;48(2):241-5. doi: 10.3109/00365521.2012.749509. Epub 2012 Dec 27.
PubMed 23268593Bhandari P, Green S, Hamanaka H, Nakajima T, Matsuda T, Saito Y, Oda I, Gotoda T. Use of Gascon and Pronase either as a pre-endoscopic drink or as targeted endoscopic flushes to improve visibility during gastroscopy: a prospective, randomized, controlled, blinded trial. Scand J Gastroenterol. 2010 Mar;45(3):357-61. doi: 10.3109/00365520903483643.
PubMed 20148732Ahsan M, Babaei L, Gholamrezaei A, Emami MH. Simethicone for the Preparation before Esophagogastroduodenoscopy. Diagn Ther Endosc. 2011;2011:484532. doi: 10.1155/2011/484532. Epub 2011 Aug 4.
PubMed 21826120Bertoni G, Gumina C, Conigliaro R, Ricci E, Staffetti J, Mortilla MG, Pacchione D. Randomized placebo-controlled trial of oral liquid simethicone prior to upper gastrointestinal endoscopy. Endoscopy. 1992 May;24(4):268-70. doi: 10.1055/s-2007-1010479.
PubMed 1612040Keeratichananont S, Sobhonslidsuk A, Kitiyakara T, Achalanan N, Soonthornpun S. The role of liquid simethicone in enhancing endoscopic visibility prior to esophagogastroduodenoscopy (EGD): A prospective, randomized, double-blinded, placebo-controlled trial. J Med Assoc Thai. 2010 Aug;93(8):892-7.
PubMed 20718163Kuo CH, Sheu BS, Kao AW, Wu CH, Chuang CH. A defoaming agent should be used with pronase premedication to improve visibility in upper gastrointestinal endoscopy. Endoscopy. 2002 Jul;34(7):531-4. doi: 10.1055/s-2002-33220.
PubMed 12170403Lee GJ, Park SJ, Kim SJ, Kim HH, Park MI, Moon W. Effectiveness of Premedication with Pronase for Visualization of the Mucosa during Endoscopy: A Randomized, Controlled Trial. Clin Endosc. 2012 Jun;45(2):161-4. doi: 10.5946/ce.2012.45.2.161. Epub 2012 Jun 30.
PubMed 22866258Fujii T, Iishi H, Tatsuta M, Hirasawa R, Uedo N, Hifumi K, Omori M. Effectiveness of premedication with pronase for improving visibility during gastroendoscopy: a randomized controlled trial. Gastrointest Endosc. 1998 May;47(5):382-7. doi: 10.1016/s0016-5107(98)70223-8.
PubMed 9609431Zala G, Flury R, Wust J, Meyenberger C, Ammann R, Wirth HP. [Omeprazole/amoxicillin: improved eradication of Helicobacter pylori in smokers because of N-acetylcysteine]. Schweiz Med Wochenschr. 1994 Aug 9;124(31-32):1391-7. German.
PubMed 8091167Chang CC, Chen SH, Lin CP, Hsieh CR, Lou HY, Suk FM, Pan S, Wu MS, Chen JN, Chen YF. Premedication with pronase or N-acetylcysteine improves visibility during gastroendoscopy: an endoscopist-blinded, prospective, randomized study. World J Gastroenterol. 2007 Jan 21;13(3):444-7. doi: 10.3748/wjg.v13.i3.444.
PubMed 17230616Chang 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 24325147Elvas L, Areia M, Brito D, Alves S, Saraiva S, Cadime AT. Premedication with simethicone and N-acetylcysteine in improving visibility during upper endoscopy: a double-blind randomized trial. Endoscopy. 2017 Feb;49(2):139-145. doi: 10.1055/s-0042-119034. Epub 2016 Nov 16.
PubMed 27852098
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premedication With Simethicone and N-acetylcysteine in Improving Mucosal Visibility During Upper Endoscopy - a Prospective Double-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02357303
- Acronym / sponsor ID
- PortugueseOIC 001
- Conditions
- Gastric Mucosal Lesion
- Keywords
- Randomized controlled trial, Endoscopy, Gastric mucosa, Simethicone, Acetylcysteine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Portuguese Oncology Institute, CoimbraUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 Feb 2015 (estimated)
- 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 upper endoscopy is one of the most common methods for the diagnosis and treatment of upper gastrointestinal (GI) tract diseases and provides a unique opportunity to identify early neoplastic lesions.
Before an upper endoscopy it is required a 6 hour fasting period[1]. However, even with this fasting period, sometimes the mucosal visualization, especially in the stomach, is impaired by the presence of foam, bubbles or gastric mucus.
To improve visualization of the gastric mucosa, it is possible to administrate an oral solution of defoaming agents such as Simethicone and mucolytic agents like Pronase or N-Acetylcysteine previously to the procedure.
The aim of this project is to determine if the use of premedication with simethicone, alone or in association with N-Acetylcysteine, improves mucosal visualization during an upper GI endoscopy.
Detailed description
- Study type: prospective, randomized, double-blinded, placebo-controlled trial: i. Prospective inclusion of patients; ii. Randomization by computer generated tables; iii. Allocation concealment by sealed, opaque envelopes; iv. Double-blinded - nurse instructed not to reveal treatment; patient and doctor unaware of treatment;
- Patient selection: consecutive series of patients scheduled for upper gastrointestinal endoscopy; Exclusion criteria - sedation, previous total gastrectomy, known neoplasia or stenosis, allergies to simethicone or N-acetylcysteine, therapeutic or urgent procedures;
- Sample size: 270 (3 groups of 90 patients): to improve "excellent" preparations from 20% (value from our own database) to 40% and assuming a normal distribution and a power of 80% (α=0.05), the calculated sample size of each of the 3 groups was 82; allowing for a 10% dropout rate, the sample size is 90 (270 patients overall); Groups: Group A - 100mL of water (placebo); Group B - 100mL of water plus 100mg Simethicone; Group C - 100mL of water plus 100mg Simethicone plus 600mg N-acetylcysteine;
- Data collection methods: form sheet filled by nurses (appendix 1) and endoscopist (appendix 2);
- Analysed variables: patients characteristics (age, gender), indication for endoscopy, time from administration to procedure, score of mucosal visualization, side effects of medication;
- Statistical analysis: chi-square test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboGroup A - 100mL of water by mouth, 15 to 30 minutes before endoscopy |
| Simethicone | Active comparator | Drug: SimethiconeGroup B - 100mL of water plus 100mg Simethicone by mouth, 15 to 30 minutes before endoscopy |
| Simethicone plus N-acetylcysteine | Active comparator | Drug: AcetylcysteineGroup C - 100mL of water plus 100mg Simethicone plus 600mg N-acetylcysteine by mouth, 15 to 30 minutes before endoscopy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- consecutive series of patients scheduled for upper gastrointestinal endoscopy
- signed informed consent
Key exclusion criteria (5 listed)
- sedation
- previous total gastrectomy
- known neoplasia or stenosis
- therapeutic or urgent procedures
- allergies to simethicone or N-acetylcysteine
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 |
|---|---|---|
| SimethiconeAlso: Aero-OM100mL of water plus 100mg Simethicone by mouth, 15 to 30 minutes before endoscopy | Drug | Simethicone |
| AcetylcysteineAlso: Fluimucil100mL of water plus 100mg Simethicone plus 600mg N-acetylcysteine by mouth, 15 to 30 minutes before endoscopy | Drug | Simethicone plus N-acetylcysteine |
| Placebo100mL of water | Other | Placebo |
Primary outcome
Score of mucosal visualization
Time frame: 1 day (During endoscopy)
Evaluation of the visibility of gastric mucosa during upper endoscopy using a scale (excelent, adequadate or inadequate) for esophagus, stomach and duodenum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Background: PubMed 12665751Faigel DO, Eisen GM, Baron TH, Dominitz JA, Goldstein JL, Hirota WK, Jacobson BC, Johanson JF, Leighton JA, Mallery JS, Raddawi HM, Vargo JJ 2nd, Waring JP, Fanelli RD, Wheeler-Harbough J; Standards of Practice Committee. American Society for Gastrointestinal Endoscopy. Preparation of patients for GI endoscopy. Gastrointest Endosc. 2003 Apr;57(4):446-50. doi: 10.1016/s0016-5107(03)80006-8. No abstract available.
- Background: PubMed 22072853Asl SM, Sivandzadeh GR. Efficacy of premedication with activated Dimethicone or N-acetylcysteine in improving visibility during upper endoscopy. World J Gastroenterol. 2011 Oct 7;17(37):4213-7. doi: 10.3748/wjg.v17.i37.4213.
- Background: PubMed 23268593Chen MJ, Wang HY, Chang CW, Hu KC, Hung CY, Chen CJ, Shih SC. The add-on N-acetylcysteine is more effective than dimethicone alone to eliminate mucus during narrow-band imaging endoscopy: a double-blind, randomized controlled trial. Scand J Gastroenterol. 2013 Feb;48(2):241-5. doi: 10.3109/00365521.2012.749509. Epub 2012 Dec 27.
- Background: PubMed 20148732Bhandari P, Green S, Hamanaka H, Nakajima T, Matsuda T, Saito Y, Oda I, Gotoda T. Use of Gascon and Pronase either as a pre-endoscopic drink or as targeted endoscopic flushes to improve visibility during gastroscopy: a prospective, randomized, controlled, blinded trial. Scand J Gastroenterol. 2010 Mar;45(3):357-61. doi: 10.3109/00365520903483643.
- Background: PubMed 21826120Ahsan M, Babaei L, Gholamrezaei A, Emami MH. Simethicone for the Preparation before Esophagogastroduodenoscopy. Diagn Ther Endosc. 2011;2011:484532. doi: 10.1155/2011/484532. Epub 2011 Aug 4.
- Background: PubMed 1612040Bertoni G, Gumina C, Conigliaro R, Ricci E, Staffetti J, Mortilla MG, Pacchione D. Randomized placebo-controlled trial of oral liquid simethicone prior to upper gastrointestinal endoscopy. Endoscopy. 1992 May;24(4):268-70. doi: 10.1055/s-2007-1010479.
- Background: PubMed 20718163Keeratichananont S, Sobhonslidsuk A, Kitiyakara T, Achalanan N, Soonthornpun S. The role of liquid simethicone in enhancing endoscopic visibility prior to esophagogastroduodenoscopy (EGD): A prospective, randomized, double-blinded, placebo-controlled trial. J Med Assoc Thai. 2010 Aug;93(8):892-7.
- Background: PubMed 12170403Kuo CH, Sheu BS, Kao AW, Wu CH, Chuang CH. A defoaming agent should be used with pronase premedication to improve visibility in upper gastrointestinal endoscopy. Endoscopy. 2002 Jul;34(7):531-4. doi: 10.1055/s-2002-33220.
- Background: PubMed 22866258Lee GJ, Park SJ, Kim SJ, Kim HH, Park MI, Moon W. Effectiveness of Premedication with Pronase for Visualization of the Mucosa during Endoscopy: A Randomized, Controlled Trial. Clin Endosc. 2012 Jun;45(2):161-4. doi: 10.5946/ce.2012.45.2.161. Epub 2012 Jun 30.
- Background: PubMed 9609431Fujii T, Iishi H, Tatsuta M, Hirasawa R, Uedo N, Hifumi K, Omori M. Effectiveness of premedication with pronase for improving visibility during gastroendoscopy: a randomized controlled trial. Gastrointest Endosc. 1998 May;47(5):382-7. doi: 10.1016/s0016-5107(98)70223-8.
- Background: PubMed 8091167Zala G, Flury R, Wust J, Meyenberger C, Ammann R, Wirth HP. [Omeprazole/amoxicillin: improved eradication of Helicobacter pylori in smokers because of N-acetylcysteine]. Schweiz Med Wochenschr. 1994 Aug 9;124(31-32):1391-7. German.
- Background: PubMed 17230616Chang CC, Chen SH, Lin CP, Hsieh CR, Lou HY, Suk FM, Pan S, Wu MS, Chen JN, Chen YF. Premedication with pronase or N-acetylcysteine improves visibility during gastroendoscopy: an endoscopist-blinded, prospective, randomized study. World J Gastroenterol. 2007 Jan 21;13(3):444-7. doi: 10.3748/wjg.v13.i3.444.
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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. This study is not recruiting at the moment.
Luís Elvas, MD principal investigator
Gastroenterology Department, Portuguese Oncology Institute - Coimbra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simethicone and Acetylcysteine in people with Gastric Mucosal Lesion, run by Portuguese Oncology Institute, Coimbra at 1 site in Portugal.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of mucosal visualization (time frame: 1 day (During endoscopy)). 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 NCT02357303, which also lists 14 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 8 Jan 2016; AzTrials last refreshed its copy on 7 Nov 2026.