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The Effects of Moviprep With Simethicone on Colonic Bubbles

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ClinicalTrials.gov Identifier: NCT01209806
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : December 8, 2014
Information provided by (Responsible Party):
Thomas Jefferson University

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.

Condition or disease Intervention/treatment
Bubbles in Colon at Time of Colonoscopy 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  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: The Effects of Moviprep With Simethicone on Colonic Bubbles
Study Start Date : November 2009
Primary Completion Date : August 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Simethicone
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Efficacy - Entire colon [ Time Frame: At time of colonoscopy ]
    Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate

Secondary Outcome Measures :
  1. Efficacy - Right colon [ Time Frame: At time of colonoscopy ]
    Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate

  2. Adenoma detection [ Time Frame: at time of colonoscopy ]
    Defined as number of adenoma/patient Secondarily evaluate % of patients with at least 1 adenoma

  3. Flushing [ Time Frame: at time of colonoscopy ]

    Defined as need for any (1, 2, or 3) flushing

    • 0 = none, 1 = <50 ml, 2 = 50-100 ml, 3 = >100 ml

  4. Tolerance [ Time Frame: during prep ingestion ]

    Prep completion

    • Completion defined as consuming > 90%


    • 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

  5. Safety [ Time Frame: at time of colonoscopy ]
    Vitals with orthostatic measures (BP, Pulse) day of colonoscopy Physical exam

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01209806

United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Principal Investigator: David Kastenberg, MD Thomas Jefferson University

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01209806     History of Changes
Other Study ID Numbers: #09D.472
First Posted: September 27, 2010    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Aluminum hydroxide, magnesium hydroxide, drug combination
Aluminum hydroxide, magnesium hydroxide, simethicone drug combination
Antifoaming Agents
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Gastrointestinal Agents
Protective Agents
Physiological Effects of Drugs