The Effects of Nexium on the Side Effects Associated With a Colonoscopy Prep
Information source: Thomas Jefferson University
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nausea; Vomiting; Abdominal Pain
Intervention: esomeprazole (PPI) (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Thomas Jefferson University Official(s) and/or principal investigator(s):
David Kastenberg, MD, Principal Investigator, Affiliation: Thomas Jefferson University
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
Clinical Details
Official title: The Effect of Esomeprazole (Nexium) on the Incidence and Severity of Gastrointestinal Adverse Events Associated With a Colonoscopy Purgative
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Primary outcome: 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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Thomas Jefferson University, Philadelphia, Pennsylvania 19107, United States
Additional Information
Starting date: December 2003
Ending date: October 2004
Last updated: February 1, 2007
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