Premedication With Simethicone or Simethicone Plus N-acetylcysteine in Improving Visibility During Upper Endoscopy

NCT01653171 | Completed Phase 4 DMC

• 1 other identifier: 12-221
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stomach Neoplasms

Keywords

Acetylcysteine, Simethicone, Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

  During diagnostic upper endoscopy

Study Arms (5)

Control

NO INTERVENTION

Standard upper endoscopy withouth premedication

Water

PLACEBO COMPARATOR

100 mL of water, 20 minutes before upper endoscopy

Drug: Water (Placebo)

Simethicone

EXPERIMENTAL

Simethicone 200 mg, in water for up to 100 mL, to take 20 minutes prior to examination

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

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

Drug: Simethicone; Drug: N-acetylcysteine 1000 mg

Interventions

Water (Placebo) DRUG

Water 100 mL

Also known as: (Placebo)

Water

Simethicone DRUG

200 mg (5 mL) in water for up to 100 mL, to take 20 minutes prior to examination

Also known as: Flapex, Andromaco, Chile

N-acetylcysteine 1000 mg + Simethicone; N-acetylcysteine 500 mg + Simethicone; Simethicone

N-acetylcysteine 500 mg DRUG

500 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination

Also known as: Mucolítico, Sanitas, Chile

N-acetylcysteine 500 mg + Simethicone

N-acetylcysteine 1000 mg DRUG

1000 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination

Also known as: Mucolítico, Sanitas, Chile

N-acetylcysteine 1000 mg + Simethicone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnostic upper endoscopy performed for medical indications

You may not qualify if:

• Upper gastrointestinal surgery
• Gastric Cancer
• Deep sedation with propofol
• Indication of therapeutic endoscopy
• Emergency endoscopy
• Patients with a history of
• Upper gastrointestinal bleeding
• Caustic ingestion
• Pregnancy
• Diabetes mellitus
• Asthma
• Allergic reactions to medication

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Hospital Clinico Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, 833-0024, Chile

Location

Related Publications (20)

• 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.

  PMID: 11857360 RESULT

• Csendes 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.

  PMID: 1305308 RESULT

• McColl KE. Screening for early gastric cancer. Gut. 2005 Jun;54(6):740-2. doi: 10.1136/gut.2004.058461. No abstract available.

  PMID: 15888773 RESULT

• Tashiro 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.

  PMID: 16937471 RESULT

• Everett 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.

  PMID: 9643813 RESULT

• Ono 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.

  PMID: 11156645 RESULT

• Chavez 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.

  PMID: 15818423 RESULT

• Federation 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.

  PMID: 15738894 RESULT

• Yoon 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.

  PMID: 22142434 RESULT

• Bhandari 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.

  PMID: 20148732 RESULT

• McDonald 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.

  PMID: 365670 RESULT

• Banerjee 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.

  PMID: 1479177 RESULT

• McNally 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.

  PMID: 3292345 RESULT

• Tongprasert 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.

  PMID: 19554657 RESULT

• Albert 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.

  PMID: 15044883 RESULT

• Fang YH, Chen CX, Zhang BL. Effect of small bowel preparation with simethicone on capsule endoscopy. J Zhejiang Univ Sci B. 2009 Jan;10(1):46-51. doi: 10.1631/jzus.B0820148.

  PMID: 19198022 RESULT

• Chang 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.

  PMID: 17230616 RESULT

• Kuo 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.

  PMID: 12170403 RESULT

• Sanchez del Rio A, Alarcon Fernandez O, Baudet JS, Sainz Menendez Z, Socas Mendez M. Reliability of the Spanish version of a brief questionnaire on patient satisfaction with gastrointestinal endoscopy. Rev Esp Enferm Dig. 2005 Aug;97(8):554-61. doi: 10.4321/s1130-01082005000800003. English, Spanish.

  PMID: 16266222 RESULT

• Principles of training in gastrointestinal endoscopy. From the ASGE. American Society for Gastrointestinal Endoscopy. Gastrointest Endosc. 1999 Jun;49(6):845-53. No abstract available.

  PMID: 10343249 RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Water; Simethicone; Acetylcysteine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Adolfo Parra-Blanco, MD

  Pontificia Universidad Catolica de Chile

  STUDY DIRECTOR

• Esteban Glasinovic, MD

  Pontificia Universidad Catolica

  PRINCIPAL INVESTIGATOR

• Hugo Monrroy, MD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

• Roberto Candia, MD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal Medicine Physician, Gastroenterology Residency Training Program

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: July 30, 2012
• Study Start: July 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 10, 2018

Record last verified: 2018-04

Locations

CL (1)