Phase 4 N=268 Randomized Double-blind Screening

Effect of Simethicone on Screening Colonoscopy

Adenoma Colon

Bottom Line

View on ClinicalTrials.gov: NCT03119168 ↗

Enrolled (actual)

268

Serious AEs

0.0%

Results posted

Jun 2019

Primary outcome: Primary: Adenoma Detection Rate — 43; 54 adenomas

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Simethicone Solution (Drug); Polyethylenglycol (Other)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: Texas Tech University Health Sciences Center, El Paso
Primary completion: Apr 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Adenoma Detection Rate	43; 54	—
SECONDARY Withdrawal Times	395.7; 399	—
SECONDARY Colon Preparation	8.9; 8.9; 0.1; 2.1	—
SECONDARY Intraprocedural Use of Simethicone	2; 68	—

Summary

This study is evaluating the effect of adding a high dose of simethicone to the standard polyethylene glycol preparation for screening colonoscopy in the quality of the preparation , adenoma detection rate and withdrawal times.

Eligibility Criteria

Inclusion Criteria

Patients between the ages of 30-80 scheduled for screening colonoscopy.
Male and female patients
Ambulatory patients
Signed informed consent form

Exclusion Criteria

Previous colonic surgery
Patient with mental/physical condition that impairs oral ingestion of preparation
Allergy or hypersensitivity to simethicone
Patients with limited mobility (bedridden patients)
Patients with gastrointestinal obstruction
Patients with gastroparesis

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03119168). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.