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

Nausea Clinical Trial

Official title:

The Effect of Esomeprazole (Nexium) on the Incidence and Severity of Gastrointestinal Adverse Events Associated With a Colonoscopy Purgative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225238
• Other study ID #: 03C.433
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2005
• Last updated: June 4, 2013
• Start date: December 2003
• Est. completion date: October 2007

Study information

• Verified date: June 2013
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Abdominal Pain
• Nausea
• Vomiting

Intervention

Drug:
• esomeprazole (PPI)

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.