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

NCT00637559 | Completed Phase 4

• 2 other identifiers: 315D9612L00056
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Barrett's Esophagus

Keywords

Nexium; Barrett's esophagus

Outcome Measures

Primary Outcomes (1)

• 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.

  pH measured on Day 5

Secondary Outcomes (1)

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

  pH measured

Study Arms (3)

1

EXPERIMENTAL

40mg twice daily

Drug: Esomeprazole Magnesium

2

EXPERIMENTAL

40mg three times daily

Drug: Esomeprazole Magnesium

3

EXPERIMENTAL

20mg three times daily

Drug: Esomeprazole Magnesium

Interventions

Esomeprazole Magnesium DRUG

Also known as: Nexium

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Paula Fernstrom

  Nexium Global Product Director, AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 11, 2008
• First Posted: March 18, 2008
• Study Start: March 1, 2002
• Primary Completion: April 1, 2003
• Study Completion: April 1, 2003
• Last Updated: January 25, 2011

Record last verified: 2011-01