NCT00402259

Brief Summary

The purpose of this study is to assess the efficacy and safety of Esomeprazole and Omeprazole intravenous every 12 hours for 5 days in subjects with acute non-variceal upper gastrointestinal bleeding

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

March 12, 2009

Status Verified

March 1, 2009

First QC Date

November 17, 2006

Last Update Submit

March 11, 2009

Conditions

Gastrointestinal Hemorrhage

Keywords

acute non-variceal upper gastrointestinal bleeding

Outcome Measures

Primary Outcomes (1)

  • Evaluate the efficacy by assessment of proportion of subjects who present with no clinically significant bleeding after 5 days treatment

Secondary Outcomes (2)

  • Proportion of subjects who present with no clinically significant upper GI bleeding after 72-hour treatment

  • Time to absence of clinically significant upper GI bleeding

Interventions

Esomeprazole IVDRUG
Omeprazole IVDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged 18-65 years.
  • GI bleeding or with such signs within 48 hours as judged by the investigator as to have non-variceal upper GI bleeding.
  • One endoscopically confirmed bleeding peptic ulcer or erosive gastritis

You may not qualify if:

  • GI bleeding caused by Esophageal varices
  • Mallory Weiss syndrome
  • Zollinger-Ellison syndrome
  • Suspicion of gastric malignancy at baseline endoscopy
  • Post-Billroth-resection
  • Unknown source of GI bleeding · 2.Unstable vital signs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Research site

Fuzhou, Fujian, China

Location

Research Site

Guangzhou, Guangdong, China

Location

Research Site

Wuhan, Hubei, China

Location

Research Site

Xi’an, Shanxi, China

Location

Research Site

Beijing, China

Location

Research Site

Shanghai, China

Location

Research Site

Tianjin, China

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tore Lind, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 17, 2006

First Posted

November 22, 2006

Study Start

August 1, 2006

Study Completion

October 1, 2007

Last Updated

March 12, 2009

Record last verified: 2009-03

Locations

CN(7)