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Safe, Effective, and More Tolerable 16 Tablets Colon Prep (ABP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00817934
Recruitment Status : Unknown
Verified January 2009 by Long Neck Medical Enterprises.
Recruitment status was:  Active, not recruiting
First Posted : January 7, 2009
Last Update Posted : January 7, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is determine if the AB Prep (a 16 tablets colon cleansing prep), is an effective, and safe colon cleansing prep in preparation for colonoscopy, and severe constipation.

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: AB PREP Phase 3

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Phase III of the AB Prep Safety and Efficacy in Colon Cleansing
Study Start Date : January 2009
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
PREVENTION AND TREATMENT
PATIENTS 50 YEARS AND OLDER REQUIRE SCREENING COLONOSCOPY. PATIENTS WITH FAMILY HISTORY OF COLON CANCER WILL REQUIRE IT BEFORE THE AGE OF 50.
Drug: AB PREP
Potassium phosphate and Sodium Phosphate,(in the form of K-phos neutral 8 tablets.(Bisacodyl)6tablets. The third medication is (Metoclopramide).
Other Name: Reglan, K-Phos neutral, and Dulcolax


Outcome Measures

Primary Outcome Measures :
  1. TOTAL COLON CLEANSING, TO BE ABLE TO PERFORM COLONOSCOPY [ Time Frame: IMMEDIATE, DURING THE COLONOSCOPY ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Any patient between the age of 12 and 75, who is eligible for colonoscopy.
Criteria

Inclusion Criteria:

  • Any eligible patient for colonoscopy

Exclusion Criteria:

  • Patients with renal failure
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00817934


Locations
United States, Delaware
Cedar Tree Surgical Center
Millsboro, Delaware, United States, 19966
Sponsors and Collaborators
Long Neck Medical Enterprises
National Institutes of Health (NIH)
Investigators
Principal Investigator: SEMAAN M ABBOUD, MD
More Information

Responsible Party: Semaan Abboud MD/ PI, Long Neck Medical Enterprises
ClinicalTrials.gov Identifier: NCT00817934     History of Changes
Other Study ID Numbers: ABBPREP1
AB1
First Posted: January 7, 2009    Key Record Dates
Last Update Posted: January 7, 2009
Last Verified: January 2009

Keywords provided by Long Neck Medical Enterprises:
Efficacy
patient's tolerance
patient's safety