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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00637559
First received: March 11, 2008
Last updated: January 24, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Barrett's Esophagus
 Drug: Esomeprazole Magnesium
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. [ Time Frame: pH measured on Day 5 ]

Secondary Outcome Measures:
  • Compare total percent time distal esophageal pH is above 4.0 at steady state for each treatment period. [ Time Frame: pH measured ]

Estimated Enrollment: 50
Study Start Date: March 2002
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
40mg twice daily
 Drug: Esomeprazole Magnesium
Other Name: Nexium
Experimental: 2
40mg three times daily
 Drug: Esomeprazole Magnesium
Other Name: Nexium
Experimental: 3
20mg three times daily
 Drug: Esomeprazole Magnesium
Other Name: Nexium

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637559

Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Paula Fernstrom Nexium Global Product Director, AstraZeneca
  More Information

No publications provided

Responsible Party: Tore Lind, MD - Nexium Medical Science Director, Astra Zeneca
ClinicalTrials.gov Identifier: NCT00637559     History of Changes
Other Study ID Numbers: 315, D9612L00056
Study First Received: March 11, 2008
Last Updated: January 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Nexium
Barrett's esophagus

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Omeprazole
 Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013