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A Safety Study of 3 Different Bowel Cleansing Preparations

NCT01501513 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 541

Last updated 2024-01-17

Study results available
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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

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

Sponsors & Collaborators

  • Braintree Laboratories

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-03-04
Completion
2013-03-04

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01501513 on ClinicalTrials.gov