The Effects of Moviprep With Simethicone on Colonic Bubbles

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01209806
First received: July 12, 2010
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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 Intervention
Bubbles in Colon at Time of Colonoscopy
Drug: simethicone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: The Effects of Moviprep With Simethicone on Colonic Bubbles

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Efficacy - Entire colon [ Time Frame: At time of colonoscopy ] [ Designated as safety issue: No ]
    Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate


Secondary Outcome Measures:
  • Efficacy - Right colon [ Time Frame: At time of colonoscopy ] [ Designated as safety issue: No ]
    Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate

  • Adenoma detection [ Time Frame: at time of colonoscopy ] [ Designated as safety issue: No ]
    Defined as number of adenoma/patient Secondarily evaluate % of patients with at least 1 adenoma

  • Flushing [ Time Frame: at time of colonoscopy ] [ Designated as safety issue: No ]

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

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


  • Tolerance [ Time Frame: during prep ingestion ] [ Designated as safety issue: No ]

    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

  • Safety [ Time Frame: at time of colonoscopy ] [ Designated as safety issue: Yes ]
    Vitals with orthostatic measures (BP, Pulse) day of colonoscopy Physical exam


Enrollment: 140
Study Start Date: November 2009
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209806

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

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01209806     History of Changes
Other Study ID Numbers: #09D.472
Study First Received: July 12, 2010
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Simethicone
Aluminum hydroxide, magnesium hydroxide, simethicone drug combination
Antifoaming Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Emollients
Dermatologic Agents
Therapeutic Uses
Antacids

ClinicalTrials.gov processed this record on August 19, 2014