NCT00164931

Brief Summary

A prospective randomized study to compare the adjunctive use of high dose omeprazole infusion against scheduled second endoscopy in prevention of peptic ulcer rebleeding after therapeutic endoscopy.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

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

October 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

June 10, 2011

Status Verified

September 1, 2005

First QC Date

September 11, 2005

Last Update Submit

June 9, 2011

Conditions

Peptic Ulcer Hemorrhage

Keywords

Peptic ulcer hemorrhageOmeprazoleScheduled second endoscopy

Outcome Measures

Primary Outcomes (7)

  • Recurrent bleeding within 30 days after initial endoscopy defined as -

  • Clinical criteria (anyone of the below)

  • 1. Haemetmesis or fresh blood from Ryles tube

  • 2. Fresh melena with shock (systolic blood pressure < 100mmHg or pulse >100/min) or drop in Hb > 2g/dl

  • 3. Haemoglobin drop for more than 4 g/dl in 24 hours before 2nd therapeutic endoscopy

  • 4. Blood transfusion of > 4 unit in 24 hours to stabilize Hb level or vital signs

  • AND Endoscopic criteria of Forrest I a, b or II a, b

Secondary Outcomes (4)

  • 1. The rate of surgery

  • 2. Mortality

  • 3. Length of Hospital stay

  • 4. Transfusion

Interventions

Intravenous omeprazole infusionDRUG
Scheduled second endoscopyPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • all consecutive patients admitted for peptic ulcer bleeding (including bleeding anastomotic ulcers) with emergency endoscopy done in 24 hours after admission with Forrest type Ia, Ib, and IIa, IIb
  • age 15 - 90 years
  • Written consent available

You may not qualify if:

  • ulcer bleeding not controlled in first endoscopy
  • Bleeding from malignant ulcer or tumor
  • Bleeding from Dieulafoy lesion/ angiodysplasia
  • Bleeding from injection sclerotherapy ulcer
  • Patient with ASA category 5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, United Christian Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal HemorrhageGastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Philip WY Chiu, MBChB, FRCSEd

    Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

  • Henry KM Joeng, MBBS

    Department of Surgery, United Christian Hospital, Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 14, 2005

Study Start

October 1, 2003

Last Updated

June 10, 2011

Record last verified: 2005-09

Locations

CN(1)