NCT00153725

Brief Summary

The aim of the study is to investigate whether intravenous infusion of pantoprazole (Pantoloc) is effective in preventing recurrent bleeding in patients who present with acute ulcer bleeding and continue to use aspirin

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

3 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

February 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

October 27, 2006

Status Verified

October 1, 2006

First QC Date

September 8, 2005

Last Update Submit

October 26, 2006

Conditions

Cardiovascular DiseaseCerebrovascular Disorders

Outcome Measures

Primary Outcomes (2)

  • Primary Outcome:

  • Recurrent upper gastrointestinal bleeding within 30 days

Interventions

Aspirin and PantolocDRUG

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients received daily anti-platelet therapy for vascular prophylaxis before admission and will continue need to do so
  • Patinets with bleeding peptic ulcers;ulcer actively bleeding or with SRH (Forrest I, IIa and IIb ulcers)
  • Endoscopic haemostasis achieved

You may not qualify if:

  • Presence of ulcer complication precluding endoscopic treatment such as gastric outlet obstruction or ulcer perforation mandating surgical intervention.
  • Concomitant use of anticoagulant, NSAIDs or steroid
  • Pending to undergo cardiac interventions that need double anti-platelet agent
  • Pregnancy
  • Terminal illness, or cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Endoscopy Center, North District Hospital

Hong Kong, China

Location

Endoscopy Center, Prince of Wales Hospital

Hong Kong, China

Location

Endoscopy Center, United Christian Hospital

Hong Kong, China

Location

Related Publications (1)

  • Sung JJ, Lau JY, Ching JY, Wu JC, Lee YT, Chiu PW, Leung VK, Wong VW, Chan FK. Continuation of low-dose aspirin therapy in peptic ulcer bleeding: a randomized trial. Ann Intern Med. 2010 Jan 5;152(1):1-9. doi: 10.7326/0003-4819-152-1-201001050-00179. Epub 2009 Nov 30.

    PMID: 19949136DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesCerebrovascular Disorders

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Joseph J Sung, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

February 1, 2003

Study Completion

September 1, 2006

Last Updated

October 27, 2006

Record last verified: 2006-10

Locations

CN(3)