NCT00817934

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

January 7, 2009

Status Verified

January 1, 2009

Enrollment Period

1 year

First QC Date

January 5, 2009

Last Update Submit

January 6, 2009

Conditions

Colon Cancer

Keywords

Efficacypatient's tolerancepatient's safety

Outcome Measures

Primary Outcomes (1)

  • TOTAL COLON CLEANSING, TO BE ABLE TO PERFORM COLONOSCOPY

    IMMEDIATE, DURING THE COLONOSCOPY

Study Arms (1)

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

Interventions

AB PREPDRUG

Potassium phosphate and Sodium Phosphate,(in the form of K-phos neutral 8 tablets.(Bisacodyl)6tablets. The third medication is (Metoclopramide).

Also known as: Reglan, K-Phos neutral, and Dulcolax
PREVENTION AND TREATMENT

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Any patient between the age of 12 and 75, who is eligible for colonoscopy.

You may qualify if:

  • Any eligible patient for colonoscopy

You may not qualify if:

  • Patients with renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedar Tree Surgical Center

Millsboro, Delaware, 19966, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

MetoclopramideBisacodyl

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic Chemicalspara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesHydroxybenzoate EthersHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenyl EthersPhenolsCresols

Study Officials

  • SEMAAN M ABBOUD, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2009

First Posted

January 7, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

January 7, 2009

Record last verified: 2009-01

Locations

US(1)