NCT01209806

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 27, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

2.8 years

First QC Date

July 12, 2010

Last Update Submit

July 12, 2019

Conditions

Bubbles in Colon at Time of Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Efficacy - Right colon

    At time of colonoscopy

  • Adenoma detection

    at time of colonoscopy

  • Flushing

    at time of colonoscopy

  • Tolerance

    during prep ingestion

  • Safety

    at time of colonoscopy

Study Arms (2)

simethicone

ACTIVE COMPARATOR
Drug: simethicone

no simethicone

NO INTERVENTION

Interventions

simethiconeDRUG

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

Also known as: 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®
simethicone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

Simethicone

Intervention Hierarchy (Ancestors)

DimethylpolysiloxanesSiliconesSiloxanesOrganosilicon CompoundsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • David Kastenberg, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2010

First Posted

September 27, 2010

Study Start

November 1, 2009

Primary Completion

August 1, 2012

Study Completion

September 1, 2012

Last Updated

July 15, 2019

Record last verified: 2019-07

Locations

US(1)