NCT00365313

Brief Summary

The purpose of this study is to compare the effect of Esomeparzole with Placebo in the Prevention of Recurrent Ulcer Bleeding in Patients Receiving a COX-2 Inhibitor

Trial Health

87
On Track

Trial Health Score

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

Enrollment
273

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2002

Typical duration 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

August 1, 2002

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
Last Updated

October 27, 2006

Status Verified

October 1, 2006

First QC Date

August 16, 2006

Last Update Submit

October 26, 2006

Conditions

ArthritisBleeding Ulcer

Keywords

celecoxiboesomeprazolearthritisulcer bleeding

Outcome Measures

Primary Outcomes (1)

  • ulcer rebleeding over period of 13 months

Secondary Outcomes (1)

  • stroke or cardio-vascular events

Interventions

celecoxib, esomeprazoleDRUG

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoscopy Center, Prince of Wales Hospital

Hong Kong, China

Location

Related Publications (1)

  • Chan FK, Wong VW, Suen BY, Wu JC, Ching JY, Hung LC, Hui AJ, Leung VK, Lee VW, Lai LH, Wong GL, Chow DK, To KF, Leung WK, Chiu PW, Lee YT, Lau JY, Chan HL, Ng EK, Sung JJ. Combination of a cyclo-oxygenase-2 inhibitor and a proton-pump inhibitor for prevention of recurrent ulcer bleeding in patients at very high risk: a double-blind, randomised trial. Lancet. 2007 May 12;369(9573):1621-6. doi: 10.1016/S0140-6736(07)60749-1.

    PMID: 17499604DERIVED

MeSH Terms

Conditions

Arthritis

Interventions

CelecoxibEsomeprazole

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOmeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesPyridinesBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Francis K Chan, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 16, 2006

First Posted

August 17, 2006

Study Start

August 1, 2002

Study Completion

June 1, 2005

Last Updated

October 27, 2006

Record last verified: 2006-10

Locations

CN(1)