The Effects of Moviprep With Simethicone on Colonic Bubbles

The purpose of this study is to determine whether the administration of PEG along with simethicone will reduce the incidence of colonic bubbles that interfere with polyp detection.

Study Overview

• Status: Completed
• Conditions: Bubbles in Colon at Time of Colonoscopy
• Intervention / Treatment: Drug: simethicone

Detailed Description

evaluating if simethicone is better than placebo at decreasing gas in the colon at time of colonoscopy so that it is easier for the endoscopist to see polyps

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-Elective outpatients undergoing colonoscopy using split dose PEG-ELS with sodium ascorbate and ascorbic acid

Exclusion Criteria:

• Unable or unwilling to give informed consent
• Age < 18 years
• Pregnant
• Breast feeding
• Established or suspected gastroparesis
• Pseudo-obstruction - established or suspected
• Severe constipation (< 1 BM a week)
• Bowel obstruction
• Greater than 50% resection of colon
• Chronic nausea or vomiting
• Consumed > 100% standard dose of PEG-ELS (i.e. more than 2L)
• G6PD deficiency
• PEG allergy
• Significant psychiatric illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: simethicone	Drug: simethicone; 400 mg simethicone at 6pm night prior to colonoscopy 400 mg simethicone 4 hours before colonoscopy; Other Names: Alka-Seltzer® Gas Relief Maximum Strength Softgels®; Flatulex® Drops; GasAid® Maximum Strength Softgels®; Gas-X®; Gas-X® Extra Strength; Gas-X® Extra Strength Liquid; Gas-X® Extra Strength Softgels®; Genasyme®; Genasyme® Drops; Maalox® Anti-Gas Extra Strength; Maalox® Anti-Gas Regular Strength; Mylanta® Gas Relief; Mylanta® Gas Relief Gelcaps®; Mylanta® Gas Relief Maximum Strength; Mylicon® Infant's Drops; Phazyme® Infant Drops; Phazyme®-125 Softgels®; Phazyme®-166 Maximum Strength; Phazyme®-166 Maximum Strength Softgels®
No Intervention: no simethicone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy - Entire colon	Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate	At time of colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy - Right colon	Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate	At time of colonoscopy
Adenoma detection	Defined as number of adenoma/patient Secondarily evaluate % of patients with at least 1 adenoma	at time of colonoscopy
Flushing	Defined as need for any (1, 2, or 3) flushing • 0 = none, 1 = <50 ml, 2 = 50-100 ml, 3 = >100 ml	at time of colonoscopy
Tolerance	Prep completion • Completion defined as consuming > 90% Sleep; Primary definition as quality of sleep; Also evaluate duration of sleep Overall satisfaction; Use visual analogue (Likert) scale Adverse events - nausea, vomiting, abdominal pain, bloating, light-headedness; Primary is incidence; Secondary is severity using Likert scale	during prep ingestion
Safety	Vitals with orthostatic measures (BP, Pulse) day of colonoscopy Physical exam	at time of colonoscopy

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: David Kastenberg, MD, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: July 12, 2010
• First Submitted That Met QC Criteria: September 24, 2010
• First Posted (Estimate): September 27, 2010

Study Record Updates

• Last Update Posted (Actual): July 15, 2019
• Last Update Submitted That Met QC Criteria: July 12, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunologic Factors; Gastrointestinal Agents; Protective Agents; Dermatologic Agents; Adjuvants, Immunologic; Antioxidants; Antifoaming Agents; Emollients; Antacids; Simethicone; TEMPO; Magnesium Hydroxide; Aluminum Hydroxide; Aluminum hydroxide, magnesium hydroxide, drug combination; Aluminum hydroxide, magnesium hydroxide, simethicone drug combination
• Other Study ID Numbers: #09D.472