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The Effects of Nexium on the Side Effects Associated With a Colonoscopy Prep

Primary Purpose

Nausea, Vomiting, Abdominal Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
esomeprazole (PPI)
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nausea focused on measuring colonoscopy prep

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject 18 or older undergoing out-patient colonoscopy Exclusion Criteria: Pregnant females Use of protein Pump Inhibitor within last 4 weeks Use of prescription strength H-2 Blocker within last 4 weeks Use of over the counter strength H-2 Blocker greater than 2x's a week Hospitalized patients PEG-EL purgative contraindicated.

Sites / Locations

  • Thomas Jefferson University

Outcomes

Primary Outcome Measures

Outcome will be measured by use of a symptom survey utilizing an analog scale. This will be done at the screen visit and prior to colonoscopy.

Secondary Outcome Measures

Full Information

First Posted
September 21, 2005
Last Updated
June 4, 2013
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT00225238
Brief Title
The Effects of Nexium on the Side Effects Associated With a Colonoscopy Prep
Official Title
The Effect of Esomeprazole (Nexium) on the Incidence and Severity of Gastrointestinal Adverse Events Associated With a Colonoscopy Purgative
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to ascertain if the use of Nexium for 7 days prior to taking a colon prep for a colonoscopy will decrease the side effects that are associated with the colon preparation
Detailed Description
The high incidence for colon cancer make it an ideal target for screening. In the United Staes there are approximately 100,00 new cases of colon cancer yearly. Typically the progression from polyps to cancer requires years. This permits a screening procedure to identify polyps befoere they are cancerous. Colon cleansing is required prior to colonoscopy. The gastrointestinal syptoms associted with colonic preps are common and oftn assoicated wwith upper gastrointestinal disorders including GERD, non-ulcer syspepsia, and gastric dysmotoility such as gastropareesis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting, Abdominal Pain
Keywords
colonoscopy prep

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
esomeprazole (PPI)
Primary Outcome Measure Information:
Title
Outcome will be measured by use of a symptom survey utilizing an analog scale. This will be done at the screen visit and prior to colonoscopy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject 18 or older undergoing out-patient colonoscopy Exclusion Criteria: Pregnant females Use of protein Pump Inhibitor within last 4 weeks Use of prescription strength H-2 Blocker within last 4 weeks Use of over the counter strength H-2 Blocker greater than 2x's a week Hospitalized patients PEG-EL purgative contraindicated.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kastenberg, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effects of Nexium on the Side Effects Associated With a Colonoscopy Prep

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