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

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.

Study Overview

• Status: Completed
• Conditions: Endoscopy; Colonoscopy; Bowel Preparation
• Intervention / Treatment: Drug: SUPREP Bowel Prep Kit; Drug: FDA approved bowel preparation containing electrolytes

• Study Type: Interventional
• Enrollment (Actual): 338
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36693
      • University of South Alabama
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Medical Center
  • Massachusetts
    • Brockton, Massachusetts, United States, 02302
      • Commonwealth Clinical Studies
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Gastrointestinal Associates
  • New York
    • Great Neck, New York, United States, 11023
      • Long Island GI Research Group
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
  • Oregon
    • Portland, Oregon, United States, 97210
      • Northwest Gastroenterology Clinic
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Franklin Gastroenterology
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.

At least 18 years of age

If female, and of child-bearing potential, is using an acceptable form of birth control

Negative urine pregnancy test at screening, if applicable

In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.

Subjects who had previous significant gastrointestinal surgeries

Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on screening laboratory results, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.

Subjects with a prior history of renal, liver or cardiac insufficiency

Subjects with impaired consciousness that predisposes them to pulmonary aspiration.

Subjects undergoing colonoscopy for foreign body removal and/or decompression.

Subjects who are pregnant or lactating, or intending to become pregnant during the study.

Subjects of childbearing potential who refuse a pregnancy test.

Subjects allergic to any preparation components.

Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.

Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.

Subjects who withdraw consent before completion of Visit 1 procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SUPREP Bowel Prep Kit	Drug: SUPREP Bowel Prep Kit; solution for oral administration prior to colonoscopy
Active Comparator: FDA approved bowel preparation; FDA approved bowel preparation containing electrolytes	Drug: FDA approved bowel preparation containing electrolytes; solution for oral administration prior to colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Subjects With a Successful Preparation (Cleaning Rated as "Good" or "Excellent")	Day of colonoscopy

Collaborators and Investigators

• Sponsor: Braintree Laboratories

Publications and helpful links

General Publications

• Rex DK, DiPalma JA, McGowan J, Cleveland Mv. A comparison of oral sulfate solution with sodium picosulfate: magnesium citrate in split doses as bowel preparation for colonoscopy. Gastrointest Endosc. 2014 Dec;80(6):1113-23. doi: 10.1016/j.gie.2014.05.329. Epub 2014 Jul 12.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: February 6, 2013
• First Submitted That Met QC Criteria: February 7, 2013
• First Posted (Estimate): February 8, 2013

Study Record Updates

• Last Update Posted (Estimate): August 8, 2014
• Last Update Submitted That Met QC Criteria: August 6, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: BLI800-480