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

Colon Cleansing Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427296
• Other study ID #: OSBP4011
• Status: Completed
• Phase: Phase 4
• First received: August 30, 2011
• Last updated: December 20, 2017
• Start date: September 16, 2011
• Est. completion date: December 9, 2014

Study information

• Verified date: December 2017
• Source: Valeant Pharmaceuticals International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2154
• Est. completion date: December 9, 2014
• Est. primary completion date: March 11, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Cleansing

Intervention

Drug:
• 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
• Oral sodium phosphate solution
OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Valeant Pharmaceuticals International, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of the Overall Colon-cleansing Scale in Each Treatment Group.		6 months