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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Long Neck Medical Enterprises.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Long Neck Medical Enterprises
ClinicalTrials.gov Identifier:
NCT00817934
First received: January 5, 2009
Last updated: January 6, 2009
Last verified: January 2009
History of Changes
  Purpose

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 Intervention Phase
Colon Cancer
 Drug: AB PREP
 Phase 3

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Phase III of the AB Prep Safety and Efficacy in Colon Cleansing

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colonoscopy
U.S. FDA Resources

Further study details as provided by Long Neck Medical Enterprises:

Primary Outcome Measures:
  • TOTAL COLON CLEANSING, TO BE ABLE TO PERFORM COLONOSCOPY [ Time Frame: IMMEDIATE, DURING THE COLONOSCOPY ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: January 2009
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Semaan Abboud MD/ PI, Long Neck Medical Enterprises
ClinicalTrials.gov Identifier: NCT00817934     History of Changes
Other Study ID Numbers: ABBPREP1, AB1
Study First Received: January 5, 2009
Last Updated: January 6, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 23, 2013