An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

October 18, 2006 updated by: Braintree Laboratories
To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of the study is to evaluate the efficacy of 2 different HalfLytely preparations to produce a clinically acceptable degree of cleansing of the bowel, sufficient for colonoscopy.

Study Type

Interventional

Enrollment

450

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
    • Florida
      • Jupiter, Florida, United States, 33458
      • Miami, Florida, United States, 33173
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
    • Maryland
      • Laurel, Maryland, United States, 20707
    • New York
      • Great Neck, New York, United States, 11023
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
    • Tennessee
      • Germantown, Tennessee, United States, 38138
    • Washington
      • Bellevue, Washington, United States, 98004
      • Spokane, Washington, United States, 99207

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 the following routinely accepted indications:

Evaluation of BE results GI bleeding Anemia of unknown etiology Neoplastic disease surveillance Endosonography Inflammatory bowel disease Unknown diarrhea or constipation etiology Polypectomy Laser therapy Routine Screening

  • At least 18 years of age
  • Otherwise in good health, as determined by physical exam and medical history
  • If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
  • 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, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
  • Subjects with impaired consciousness that predisposes them to pulmonary aspiration
  • Subjects who are undergoing colonoscopy for foreign body removal and decompression
  • Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics
  • Subjects who are taking drugs that may affect electrolyte levels
  • Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments for the duration of the study
  • Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia
  • Subjects who are pregnant or lactating, or intending to become pregnant during the study
  • Subjects of childbearing potential who refuse a pregnancy test
  • Subjects who are 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 clinical, surgical, drug, or device study within the past 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy - preparation quality using a 4-point scale

Secondary Outcome Measures

Outcome Measure
Safety - patient-reported preparation related side-effects

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Braintree Laboratories

Investigators

  • Principal Investigator: Michael Goldstein, M.D., Long Island GI Research Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion

August 1, 2006

Study Registration Dates

First Submitted

January 13, 2006

First Submitted That Met QC Criteria

January 13, 2006

First Posted (Estimate)

January 19, 2006

Study Record Updates

Last Update Posted (Estimate)

October 19, 2006

Last Update Submitted That Met QC Criteria

October 18, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F38-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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