The Effects of Nexium on the Side Effects Associated With a Colonoscopy Prep - Full Text View

Sponsor:	Thomas Jefferson University
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00225238

Purpose

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

Condition	Intervention	Phase
Nausea Vomiting Abdominal Pain	Drug: esomeprazole (PPI)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	The Effect of Esomeprazole (Nexium) on the Incidence and Severity of Gastrointestinal Adverse Events Associated With a Colonoscopy Purgative

Resource links provided by NLM:

MedlinePlus related topics: Abdominal Pain Colonoscopy Nausea and Vomiting

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

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.

Enrollment:	500
Study Start Date:	December 2003
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225238

Locations

United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Thomas Jefferson University

Investigators

Principal Investigator:

David Kastenberg, MD

Thomas Jefferson University

More Information

No publications provided

Responsible Party:	David Kastenberg, MD, Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00225238 History of Changes
Other Study ID Numbers:	03C.433
Study First Received:	September 21, 2005
Last Updated:	August 19, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Thomas Jefferson University:

colonoscopy prep

Additional relevant MeSH terms:

Abdominal Pain
Nausea
Vomiting
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Omeprazole

Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012