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BLI800-480: A Safety and Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

NCT01786629 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2014-08-08

Study results available
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Summary

To compare the safety, tolerance and efficacy of SUPREP Bowel Prep Kit to an FDA approved control as bowel preparations prior to colonoscopy in adult patients.

Conditions

  • Colonoscopy
  • Bowel Preparation
  • Endoscopy

Interventions

DRUG

SUPREP Bowel Prep Kit

solution for oral administration prior to colonoscopy

DRUG

FDA approved bowel preparation containing electrolytes

solution for oral administration prior to colonoscopy

Sponsors & Collaborators

  • Braintree Laboratories

    lead INDUSTRY

Principal Investigators

  • John McGowan, MPH · Braintree Laboratories, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-05-31

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 NCT01786629 on ClinicalTrials.gov