Overview

This trial is active, not recruiting.

Condition colon cleansing
Treatments polyethylene glycol, oral sodium phosphate solution
Phase phase 4
Sponsor Salix Pharmaceuticals
Start date August 2011
End date December 2014
Trial size 2000 participants
Trial identifier NCT01427296, OSBP4011

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
oral sodium phosphate solution
OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
(Active Comparator)
polyethylene glycol
HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L

Primary Outcomes

Measure
The number of Acute Kidney Injury events relative to person-time on study
time frame: up to 6 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title A Phase 4, Randomized, Active Comparator, Open-Label, Multicenter Study to Assess the Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Salix Pharmaceuticals.