DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Barrett's Esophagus - 315 - 3 Way Cross-Over

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Barrett's Esophagus

Intervention: Esomeprazole Magnesium (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Paula Fernstrom, Study Director, Affiliation: Nexium Global Product Director, AstraZeneca

Summary

This study looks the intragastric and intraesophageal pH in patients with documented Barrett's esophagus whilst taking esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily.

Clinical Details

Official title: A Multicenter, Double-blind, Three-way Crossover Intraesophageal and Intragastric pH Study of Three Esomeprazole Treatment Regimens in Documented Barrett's Esophagus Patients

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: To compare the total percent time during the 24-hour monitoring period that gastric pH is above 4.0 at steady state in patients when taking: esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily.

Secondary outcome: Compare total percent time distal esophageal pH is above 4.0 at steady state for each treatment period.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Must have a previously established, biopsy-proven diagnosis of Barrett's esophagus

with segment length greater than 3cm, with no dysplasia or adenocarcinoma within the previous 12 months Exclusion Criteria:

- A history of esophageal, gastric, or duodenal surgery, including anti-reflux surgery

or endoscopic anti-reflux procedures, except for simple closure of a gastric or duodenal ulcer.

- History of various gastrointestinal diseases - please see investigator for full list.

- Evidence of any malignant disease in the last 5 years, except minor superficial skin

disease.

- Unstable diabetes mellitus. Stable on a controlled diet, oral agents or insulin are

acceptable.

Locations and Contacts

Additional Information

Starting date: March 2002
Last updated: January 24, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017