CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 541 enrolled
Drug / intervention
PEG-3350 based bowel preparation +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01501513
NCT01501513Phase 3Completed
CompareCT.gov

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

Braintree Laboratories·interventional·Posted Dec 29, 2011·Updated Jan 17, 2024

In Brief

A Phase 3 clinical trial evaluating PEG-3350 based bowel preparation, BLI800 approved preparation regimen, and 1 other intervention for Colonoscopy and 2 related conditions. Completed, enrolled 541 participants across 17 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColonoscopy, Bowel Preparation, Endoscopy
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 29, 2011
Enrollment StartDec 1, 2011
Primary CompletionMar 4, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.5 years ago

Interventions

PEG-3350 based bowel preparationdrug

solution for oral administration prior to colonoscopy

BLI800 approved preparation regimendrug

solution for oral administration prior to colonoscopy

BLI800 investigational preparation regimendrug

solution for oral administration prior to colonoscopy