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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00225238
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : June 5, 2013
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

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

Condition or disease Intervention/treatment Phase
Nausea Vomiting Abdominal Pain Drug: esomeprazole (PPI) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Study Start Date : December 2003
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy




Primary Outcome Measures :
  1. 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225238


Locations
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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
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Principal Investigator: David Kastenberg, MD Thomas Jefferson University

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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00225238    
Other Study ID Numbers: 03C.433
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013
Keywords provided by Thomas Jefferson University:
colonoscopy prep
Additional relevant MeSH terms:
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Vomiting
Abdominal Pain
Signs and Symptoms, Digestive
Signs and Symptoms
Pain
Neurologic Manifestations
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action