Phase 4 N=2,092 Randomized Treatment

Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing

Colon Cleansing

Bottom Line

View on ClinicalTrials.gov: NCT01427296 ↗

Enrolled (actual)

2,092

Serious AEs

1.9%

Results posted

Jan 2018

Primary outcome: Primary: Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. — 618; 243; 275; 423 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Polyethylene glycol (Drug); Oral sodium phosphate solution (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bausch Health Americas, Inc.
Primary completion: Mar 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Distribution of the Overall Colon-cleansing Scale in Each Treatment Group.	618; 243; 275; 423; 116; 286	—

Summary

The purpose of this study is to compare the safety and efficacy of OsmoPrep tablets versus HalfLytely and Bisacodyl Tablet Bowel Prep Kit in subjects who are undergoing colonoscopy.

Eligibility Criteria

Inclusion Criteria

Between 18 and 70 years of age, inclusive
Scheduled for colonoscopy within 21 days of the screening visit
Able to swallow tablets the size of a multivitamin without difficulty

Exclusion Criteria

History of biopsy-proven acute phosphate nephropathy
Known allergy or hypersensitivity to treatment arms
History of gastric stapling or bypass procedure or history of gastric retention
History of any other sodium phosphate preparation within 6 months prior to colonoscopy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01427296). 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.