NCT00040495

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of intravenous pantoprazole in the prevention of rebleeding in patients with bleeding peptic ulcer disease after successful endoscopic hemostatic therapy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
149

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2001

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

April 1, 2001

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2002

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

1.8 years

First QC Date

June 26, 2002

Last Update Submit

February 7, 2013

Conditions

Peptic Ulcer Hemorrhage

Keywords

PepticUlcerHemorrhage

Interventions

PantoprazoleDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must be men or non-pregnant women at least 18 years of age
  • Patients who present with a gastric or duodenal ulcer

You may not qualify if:

  • Patients with ulcer appearance of clean base (non-oozing, non-spurting) or flat pigmented spot; adherent clots not removed by irrigation
  • Patients presenting with active bleeding and/or NBVV at 2 or more separate sites
  • Patients with any severe concomitant diseases, eg, end stage liver or renal disease, or unstable cardiovascular, pulmonary, renal, hepatic, or gastrointestinal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Peptic Ulcer HemorrhageUlcerHemorrhage

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Gastrointestinal HemorrhageGastrointestinal DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Medical Monitor, MD

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
PREVENTION
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2002

First Posted

June 28, 2002

Study Start

April 1, 2001

Primary Completion

January 1, 2003

Study Completion

January 1, 2003

Last Updated

February 8, 2013

Record last verified: 2013-02