Stomach NeoplasmsPhase 4PRUENCT01653171
Premedication With Simethicone or Simethicone Plus N-acetylcysteine in Improving Visibility During Upper Endoscopy
A Phase 4 study testing Simethicone, N-acetylcysteine 500 mg and N-acetylcysteine 1000 mg in people with Stomach Neoplasms, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The purpose of this study is to determine whether premedication with Simethicone or Simethicone plus N-acetylcysteine are effective improving visibility during Upper endoscopy compared with use of water or no preparation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Simethicone, N-acetylcysteine 500 mg and N-acetylcysteine 1000 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 1 siteChile
- Study dates
- Jul 2012to Nov 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnostic upper endoscopy performed for medical indications
Who cannot join
- Upper gastrointestinal surgery
- Gastric Cancer
- Deep sedation with propofol
- Indication of therapeutic endoscopy
- Emergency endoscopy
- Patients with a history of
Show all 12Show fewer
- Upper gastrointestinal bleeding
- Caustic ingestion
- Pregnancy
- Diabetes mellitus
- Asthma
- Allergic reactions to medication
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital Clinico Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, 833-0024
About this study
Official title: Effectiveness of Premedication With Simethicone or Simethicone Plus N-acetylcysteine vs. Placebo in Improving Visibility During Upper Endoscopy.
The purpose of this study is to determine whether premedication with Simethicone or Simethicone plus N-acetylcysteine are effective improving visibility during Upper endoscopy compared with use of water or no preparation.
Read the detailed description
While globally there has been a downward trend in the incidence of gastric cancer, it remains the second leading cause of cancer mortality in the world. In Chile is the leading cause of death from malignant tumors in both sexes, and is recognized as a problem and public health priority in our country. Detection of gastric cancer in early stages has a huge impact on healing and therefore the prognosis of patients. In countries like Japan, where the incidence of this neoplasm is one of the highest in the world, mass screening programs have failed to demonstrate significant impact at the population level, there is a body of evidence to support endoscopic screening especially with the advent of new minimally invasive procedures such as endoscopic mucosal resection for gastric cancers detected in early stages. In our country, it is estimated that about half of the patients already have lymph node metastases or involvement of adjacent organs at diagnosis. The best way to reduce disease burden from this disease would be through primary prevention interventions or effective early detection. For this purpose the upper gastrointestinal endoscopy is the method of choice to examine the gastric mucosa in search of early lesions, and this is the point where adequate visibility of the mucosa is overriding. Mucus, foam and bubbles accumulated in the gastrointestinal tract mucosa interfere with adequate endoscopic visualization and thus represent risk of failing to diagnose early lesions. For this reason is that various anti-foam agents, anti-bubbles are widely used in endoscopic centers mainly in Japan, where its use is almost a rule, unlike the West where its use is limited by the theoretical risk of aspiration. Simethicone has been proven as a good anti-foam agent prior to endoscopy to remove mucus and bubbles. It has also been studied in other scenarios such as colonoscopy as an additive in the preparation of the colon to eliminate bubbles in endoscopic capsule for small bowel preparation as well as Endoscopic Ultrasound which reduces artifacts and increases the accuracy of the study. Currently N-acetylcysteine, a mucolytic agent, either alone or in combination with Simethicone has proven effective in removing mucus and gastric bubbles when used 20 minutes prior to the upper endoscopy, improving the visualization of the gastric mucosa. Other agents such as pronase have also been described as useful in this task are not yet available in our area. In the context of the relevance of gastric cancer in our environment, our low rate of early cancer detection and the absence of national policies on the preparation and agents that may improve visualization of the mucosa, this study aims to compare the effect of products available in our country in preparation for an endoscopy in order to improve visualization of the mucosa and increase the chance of recognizing early lesions.
- Conditions
- Stomach Neoplasms
- Being tested
- Water (Placebo), Simethicone, N-acetylcysteine 500 mg, N-acetylcysteine 1000 mg
- Keywords
- Acetylcysteine, Simethicone, Stomach Neoplasms
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water (Placebo)Drug
Also called (Placebo)
Water 100 mL
SimethiconeDrug
Also called Flapex, Andromaco, Chile
200 mg (5 mL) in water for up to 100 mL, to take 20 minutes prior to examination
N-acetylcysteine 500 mgDrug
Also called Mucolítico, Sanitas, Chile
500 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination
N-acetylcysteine 1000 mgDrug
Also called Mucolítico, Sanitas, Chile
1000 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard upper endoscopy withouth premedication |
| Water | Placebo comparator | 100 mL of water, 20 minutes before upper endoscopy Receives: Drug: Water (Placebo) |
| Simethicone | Experimental | Simethicone 200 mg, in water for up to 100 mL, to take 20 minutes prior to examination Receives: Drug: Simethicone |
| N-acetylcysteine 500 mg + Simethicone | Experimental | N-acetylcysteine 500 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination Receives: Drug: Simethicone; Drug: N-acetylcysteine 500 mg |
| N-acetylcysteine 1000 mg + Simethicone | Experimental | N-acetylcysteine 1000 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination Receives: Drug: Simethicone; Drug: N-acetylcysteine 1000 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visibility at upper endoscopy
The antrum, proximal part of the greater curvature, distal part of the greater curvature and the gastric fundus were assessed separately in terms of visibility mucosa. He scored from 1 to 4 each zone according to a score of visibility, as defined in previous publications by Chang et al. The sum of the scores from the four locations was defined as the total mucosal visibility score (TMVS) for each patient
Measured: During diagnostic upper endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hugo Monrroy, Pontificia Universidad Catolica de Chile
- Investigators
- Adolfo Parra-Blanco, MD, Study director, Pontificia Universidad Catolica de ChileEsteban Glasinovic, MD, Principal investigator, Pontificia Universidad CatolicaHugo Monrroy, MD, Principal investigator, Pontificia Universidad Catolica de ChileRoberto Candia, MD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653171
- Sponsor's protocol ID
- 12-221
- Acronym
- PRUE
- Status last verified
- Apr 2018
- First submitted
- 26 Jul 2012
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lambert R, Guilloux A, Oshima A, Pompe-Kirn V, Bray F, Parkin M, Ajiki W, Tsukuma H. Incidence and mortality from stomach cancer in Japan, Slovenia and the USA. Int J Cancer. 2002 Feb 20;97(6):811-8. doi: 10.1002/ijc.10150.
PubMed 11857360Csendes A, Smok G, Medina E, Salgado I, Rivera R, Quitral M. [Clinical course characteristics of gastric cancer 1958-1990]. Rev Med Chil. 1992 Jan;120(1):36-42. Spanish.
PubMed 1305308McColl KE. Screening for early gastric cancer. Gut. 2005 Jun;54(6):740-2. doi: 10.1136/gut.2004.058461. No abstract available.
PubMed 15888773Tashiro A, Sano M, Kinameri K, Fujita K, Takeuchi Y. Comparing mass screening techniques for gastric cancer in Japan. World J Gastroenterol. 2006 Aug 14;12(30):4873-4. doi: 10.3748/wjg.v12.i30.4873.
PubMed 16937471Everett SM, Axon AT. Early gastric cancer: disease or pseudo-disease? Lancet. 1998 May 2;351(9112):1350-2. doi: 10.1016/s0140-6736(98)04365-7. No abstract available.
PubMed 9643813Ono H, Kondo H, Gotoda T, Shirao K, Yamaguchi H, Saito D, Hosokawa K, Shimoda T, Yoshida S. Endoscopic mucosal resection for treatment of early gastric cancer. Gut. 2001 Feb;48(2):225-9. doi: 10.1136/gut.48.2.225.
PubMed 11156645Chavez Rossell M. [Endoscopic treatment of early gastric cancer: from Endoscopic Mucosal Resection (EMR) to Endoscopic Submucosal Dissection (ESD)]. Rev Gastroenterol Peru. 2005 Jan-Mar;25(1):76-92. Spanish.
PubMed 15818423Federation nationale des centres de lutte contre le cancer. [Recommendations for clinical practice: 2004 Standards, Options and Recommendations for management of patients with adenocarcinomas of the stomach (excluding cardial and other histological forms of cancer) Federation nationale des centres de lutte contre le cancer]. Gastroenterol Clin Biol. 2005 Jan;29(1):41-55. doi: 10.1016/s0399-8320(05)80692-x. No abstract available. French.
PubMed 15738894Yoon H, Kim N, Lee HS, Shin CM, Park YS, Lee DH, Park DJ, Kim HH, Jung HC. Effect of endoscopic screening at 1-year intervals on the clinicopathologic characteristics and treatment of gastric cancer in South Korea. J Gastroenterol Hepatol. 2012 May;27(5):928-34. doi: 10.1111/j.1440-1746.2011.07038.x.
PubMed 22142434Bhandari 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 20148732McDonald GB, O'Leary R, Stratton C. Pre-endoscopic use of oral simethicone. Gastrointest Endosc. 1978 Nov;24(6):283. doi: 10.1016/s0016-5107(78)73542-x. No abstract available.
PubMed 365670Banerjee B, Parker J, Waits W, Davis B. Effectiveness of preprocedure simethicone drink in improving visibility during esophagogastroduodenoscopy: a double-blind, randomized study. J Clin Gastroenterol. 1992 Oct;15(3):264-5. No abstract available.
PubMed 1479177McNally PR, Maydonovitch CL, Wong RK. The effectiveness of simethicone in improving visibility during colonoscopy: a double-blind randomized study. Gastrointest Endosc. 1988 May-Jun;34(3):255-8. doi: 10.1016/s0016-5107(88)71324-3.
PubMed 3292345Tongprasert S, Sobhonslidsuk A, Rattanasiri S. Improving quality of colonoscopy by adding simethicone to sodium phosphate bowel preparation. World J Gastroenterol. 2009 Jun 28;15(24):3032-7. doi: 10.3748/wjg.15.3032.
PubMed 19554657Albert J, Gobel CM, Lesske J, Lotterer E, Nietsch H, Fleig WE. Simethicone for small bowel preparation for capsule endoscopy: a systematic, single-blinded, controlled study. Gastrointest Endosc. 2004 Apr;59(4):487-91. doi: 10.1016/s0016-5107(04)00003-3.
PubMed 15044883
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Premedication With Simethicone or Simethicone Plus N-acetylcysteine vs. Placebo in Improving Visibility During Upper Endoscopy.
- ClinicalTrials.gov ID
- NCT01653171
- Acronym / sponsor ID
- PRUE / 12-221
- Conditions
- Stomach Neoplasms
- Keywords
- Acetylcysteine, Simethicone, Stomach Neoplasms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 30 Jul 2012 (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 purpose of this study is to determine whether premedication with Simethicone or Simethicone plus N-acetylcysteine are effective improving visibility during Upper endoscopy compared with use of water or no preparation.
Detailed description
While globally there has been a downward trend in the incidence of gastric cancer, it remains the second leading cause of cancer mortality in the world. In Chile is the leading cause of death from malignant tumors in both sexes, and is recognized as a problem and public health priority in our country. Detection of gastric cancer in early stages has a huge impact on healing and therefore the prognosis of patients. In countries like Japan, where the incidence of this neoplasm is one of the highest in the world, mass screening programs have failed to demonstrate significant impact at the population level, there is a body of evidence to support endoscopic screening especially with the advent of new minimally invasive procedures such as endoscopic mucosal resection for gastric cancers detected in early stages. In our country, it is estimated that about half of the patients already have lymph node metastases or involvement of adjacent organs at diagnosis. The best way to reduce disease burden from this disease would be through primary prevention interventions or effective early detection. For this purpose the upper gastrointestinal endoscopy is the method of choice to examine the gastric mucosa in search of early lesions, and this is the point where adequate visibility of the mucosa is overriding. Mucus, foam and bubbles accumulated in the gastrointestinal tract mucosa interfere with adequate endoscopic visualization and thus represent risk of failing to diagnose early lesions. For this reason is that various anti-foam agents, anti-bubbles are widely used in endoscopic centers mainly in Japan, where its use is almost a rule, unlike the West where its use is limited by the theoretical risk of aspiration. Simethicone has been proven as a good anti-foam agent prior to endoscopy to remove mucus and bubbles. It has also been studied in other scenarios such as colonoscopy as an additive in the preparation of the colon to eliminate bubbles in endoscopic capsule for small bowel preparation as well as Endoscopic Ultrasound which reduces artifacts and increases the accuracy of the study. Currently N-acetylcysteine, a mucolytic agent, either alone or in combination with Simethicone has proven effective in removing mucus and gastric bubbles when used 20 minutes prior to the upper endoscopy, improving the visualization of the gastric mucosa. Other agents such as pronase have also been described as useful in this task are not yet available in our area. In the context of the relevance of gastric cancer in our environment, our low rate of early cancer detection and the absence of national policies on the preparation and agents that may improve visualization of the mucosa, this study aims to compare the effect of products available in our country in preparation for an endoscopy in order to improve visualization of the mucosa and increase the chance of recognizing early lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard upper endoscopy withouth premedication |
| Water | Placebo comparator | Drug: Water (Placebo)100 mL of water, 20 minutes before upper endoscopy |
| Simethicone | Experimental | Drug: SimethiconeSimethicone 200 mg, in water for up to 100 mL, to take 20 minutes prior to examination |
| N-acetylcysteine 500 mg + Simethicone | Experimental | Drug: Simethicone, Drug: N-acetylcysteine 500 mgN-acetylcysteine 500 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination |
| N-acetylcysteine 1000 mg + Simethicone | Experimental | Drug: Simethicone, Drug: N-acetylcysteine 1000 mgN-acetylcysteine 1000 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnostic upper endoscopy performed for medical indications
Key exclusion criteria (12 listed)
- Upper gastrointestinal surgery
- Gastric Cancer
- Deep sedation with propofol
- Indication of therapeutic endoscopy
- Emergency endoscopy
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 |
|---|---|---|
| Water (Placebo)Also: (Placebo)Water 100 mL | Drug | Water |
| SimethiconeAlso: Flapex, Andromaco, Chile200 mg (5 mL) in water for up to 100 mL, to take 20 minutes prior to examination | Drug | N-acetylcysteine 1000 mg + Simethicone, N-acetylcysteine 500 mg + Simethicone, Simethicone |
| N-acetylcysteine 500 mgAlso: Mucolítico, Sanitas, Chile500 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination | Drug | N-acetylcysteine 500 mg + Simethicone |
| N-acetylcysteine 1000 mgAlso: Mucolítico, Sanitas, Chile1000 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination | Drug | N-acetylcysteine 1000 mg + Simethicone |
Primary outcome
Visibility at upper endoscopy
Time frame: During diagnostic upper endoscopy
The antrum, proximal part of the greater curvature, distal part of the greater curvature and the gastric fundus were assessed separately in terms of visibility mucosa. He scored from 1 to 4 each zone according to a score of visibility, as defined in previous publications by Chang et al. The sum of the scores from the four locations was defined as the total mucosal visibility score (TMVS) for each patient
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 10 Apr 2018.
- Results publication: PubMed 11857360Lambert R, Guilloux A, Oshima A, Pompe-Kirn V, Bray F, Parkin M, Ajiki W, Tsukuma H. Incidence and mortality from stomach cancer in Japan, Slovenia and the USA. Int J Cancer. 2002 Feb 20;97(6):811-8. doi: 10.1002/ijc.10150.
- Results publication: PubMed 1305308Csendes A, Smok G, Medina E, Salgado I, Rivera R, Quitral M. [Clinical course characteristics of gastric cancer 1958-1990]. Rev Med Chil. 1992 Jan;120(1):36-42. Spanish.
- Results publication: PubMed 15888773McColl KE. Screening for early gastric cancer. Gut. 2005 Jun;54(6):740-2. doi: 10.1136/gut.2004.058461. No abstract available.
- Results publication: PubMed 16937471Tashiro A, Sano M, Kinameri K, Fujita K, Takeuchi Y. Comparing mass screening techniques for gastric cancer in Japan. World J Gastroenterol. 2006 Aug 14;12(30):4873-4. doi: 10.3748/wjg.v12.i30.4873.
- Results publication: PubMed 9643813Everett SM, Axon AT. Early gastric cancer: disease or pseudo-disease? Lancet. 1998 May 2;351(9112):1350-2. doi: 10.1016/s0140-6736(98)04365-7. No abstract available.
- Results publication: PubMed 11156645Ono H, Kondo H, Gotoda T, Shirao K, Yamaguchi H, Saito D, Hosokawa K, Shimoda T, Yoshida S. Endoscopic mucosal resection for treatment of early gastric cancer. Gut. 2001 Feb;48(2):225-9. doi: 10.1136/gut.48.2.225.
- Results publication: PubMed 15818423Chavez Rossell M. [Endoscopic treatment of early gastric cancer: from Endoscopic Mucosal Resection (EMR) to Endoscopic Submucosal Dissection (ESD)]. Rev Gastroenterol Peru. 2005 Jan-Mar;25(1):76-92. Spanish.
- Results publication: PubMed 15738894Federation nationale des centres de lutte contre le cancer. [Recommendations for clinical practice: 2004 Standards, Options and Recommendations for management of patients with adenocarcinomas of the stomach (excluding cardial and other histological forms of cancer) Federation nationale des centres de lutte contre le cancer]. Gastroenterol Clin Biol. 2005 Jan;29(1):41-55. doi: 10.1016/s0399-8320(05)80692-x. No abstract available. French.
- Results publication: PubMed 22142434Yoon H, Kim N, Lee HS, Shin CM, Park YS, Lee DH, Park DJ, Kim HH, Jung HC. Effect of endoscopic screening at 1-year intervals on the clinicopathologic characteristics and treatment of gastric cancer in South Korea. J Gastroenterol Hepatol. 2012 May;27(5):928-34. doi: 10.1111/j.1440-1746.2011.07038.x.
- Results publication: 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.
- Results publication: PubMed 365670McDonald GB, O'Leary R, Stratton C. Pre-endoscopic use of oral simethicone. Gastrointest Endosc. 1978 Nov;24(6):283. doi: 10.1016/s0016-5107(78)73542-x. No abstract available.
- Results publication: PubMed 1479177Banerjee B, Parker J, Waits W, Davis B. Effectiveness of preprocedure simethicone drink in improving visibility during esophagogastroduodenoscopy: a double-blind, randomized study. J Clin Gastroenterol. 1992 Oct;15(3):264-5. No abstract available.
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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.
Adolfo Parra-Blanco, MD study director
Pontificia Universidad Catolica de Chile
Esteban Glasinovic, MD principal investigator
Pontificia Universidad Catolica
Hugo Monrroy, MD principal investigator
Pontificia Universidad Catolica de Chile
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, N-acetylcysteine 500 mg and N-acetylcysteine 1000 mg in people with Stomach Neoplasms, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 1 inclusion and 12 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 10 Apr 2018. 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 Chile. 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?
Visibility at upper endoscopy (time frame: During diagnostic upper 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 NCT01653171, which also lists 20 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 10 Apr 2018.