The Effects of Moviprep With Simethicone on Colonic Bubbles

• Sponsor: Thomas Jefferson University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01209806
• Collaborator: (none)
• Enrollment: 140
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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	Phase
Bubbles in Colon at Time of Colonoscopy	Drug: simethicone	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Other
• Official Title: The Effects of Moviprep With Simethicone on Colonic Bubbles
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Efficacy - Entire colon [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 [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 [at time of colonoscopy]

   Defined as number of adenoma/patient Secondarily evaluate % of patients with at least 1 adenoma

3. Flushing [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 [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

5. Safety [at time of colonoscopy]

   Vitals with orthostatic measures (BP, Pulse) day of colonoscopy Physical exam

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Thomas Jefferson University

Investigators

• Principal Investigator: David Kastenberg, MD, Thomas Jefferson University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas Jefferson University
• ClinicalTrials.gov Identifier: NCT01209806
• Other Study ID Numbers: #09D.472
• First Posted: Sep 27, 2010
• Last Update Posted: Jul 15, 2019
• Last Verified: Jul 1, 2019

• Additional relevant MeSH terms: Simethicone; Aluminum hydroxide, magnesium hydroxide, drug combination; Aluminum Hydroxide; Magnesium Hydroxide; Aluminum hydroxide, magnesium hydroxide, simethicone drug combination; TEMPO

Study Results

No Results Posted as of Jul 15, 2019