The Effects of Moviprep With Simethicone on Colonic Bubbles

NCT ID: NCT01209806

Last Updated: 2019-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Bubbles in Colon at Time of Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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simethicone

Group Type ACTIVE_COMPARATOR

simethicone

Intervention Type DRUG

400 mg simethicone at 6pm night prior to colonoscopy 400 mg simethicone 4 hours before colonoscopy

no simethicone

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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simethicone

400 mg simethicone at 6pm night prior to colonoscopy 400 mg simethicone 4 hours before colonoscopy

Intervention Type DRUG

Other Intervention Names

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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®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Kastenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

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Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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#09D.472

Identifier Type: -

Identifier Source: org_study_id

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