NCT01501513

A Safety Study of 3 Different Bowel Cleansing Preparations

A Safety, Tolerance and Efficacy Evaluation of 3 Different Bowel Cleansing Preparations in Adult Subjects, Including the Elderly and Subjects With Hepatic or Renal Insufficiency

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 541 (actual)
• Sponsor: Braintree Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare the safety, tolerance and efficacy of BLI800 (approved and investigational regimens) to an approved control preparation as bowel preparations prior to colonoscopy in adult patients, particularly including the elderly and those with renal and/or hepatic impairment.

Conditions

• Colonoscopy
• Bowel Preparation
• Endoscopy

Interventions

Type	Name	Description
DRUG	PEG-3350 based bowel preparation	solution for oral administration prior to colonoscopy
DRUG	BLI800 approved preparation regimen	solution for oral administration prior to colonoscopy
DRUG	BLI800 investigational preparation regimen	solution for oral administration prior to colonoscopy

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-03-04
• Completion: 2013-03-04
• First posted: 2011-12-29
• Last updated: 2024-01-17
• Results posted: 2024-01-17

Locations

17 sites across 1 country: United States