Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Completed
NCT Number: NCT01209806
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Simethicone
Drug400 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®
Primary outcomes
-
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 outcomes
-
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
-
Adenoma detection
Time frame: at time of colonoscopy
Defined as number of adenoma/patient Secondarily evaluate % of patients with at least 1 adenoma
-
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
-
Tolerance
Time frame: during prep ingestion
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
Vitals with orthostatic measures (BP, Pulse) day of colonoscopy Physical exam
Sponsors and collaborators
Lead sponsor
Thomas Jefferson University
Other
Registry information
Important dates
- Study start
- 2009
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Sep 27, 2010
- Registry last updated
- Jul 15, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.