NCT00153660

Brief Summary

The aim of this study is to compare celecoxib plus a PPI (esomeprazole) versus naproxen plus a PPI (esomeprazole) in preventing recurrent ulcer bleeding in arthritis patients with a history of ulcer bleeding who require concomitant ASA. We hypothesized that among patients with a history of ulcer bleeding who require concomitant ASA, celecoxib plus esomprazole would be superior to naproxen plus esomeprazole for the prevention of recurrent ulcer bleeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
514

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2005

Longer than 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

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 2, 2017

Status Verified

December 1, 2016

Enrollment Period

9.4 years

First QC Date

September 7, 2005

Last Update Submit

December 30, 2016

Conditions

ArthritisCardiovascular DiseasesCerebrovascular Disorders

Outcome Measures

Primary Outcomes (1)

  • Recurrent ulcer bleeding within 18 months according to pre-specified criteria

    18 months

Secondary Outcomes (5)

  • patients' global assessment of arthritis

    18 months

  • major CV events according to the Antithrombotic Trialists' criteria

    18 months

  • non-fatal myocardial infarction

    18 months

  • non-fatal stroke

    18 months

  • death from a vascular cause

    18 months

Study Arms (2)

NSAID #1

ACTIVE COMPARATOR

Celecoxib and Naproxen Placebo

Drug: Celecoxib(drug)

NSAID #2

ACTIVE COMPARATOR

Naproxen and Celecoxib Placebo

Drug: Naproxen(drug)

Interventions

Celecoxib(drug)DRUG

Celecoxib 100 mg bd

Also known as: Celebrex
NSAID #1
Naproxen(drug)DRUG

Naproxen 500 mg bd

Also known as: Naprosyn
NSAID #2

Eligibility Criteria

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

You may qualify if:

  • age \>18,
  • a history of endoscopically proven gastroduodenal ulcer bleeding,
  • H. pylori negative
  • a history of cardiothrombotic disease requiring ASA, and
  • anticipated regular use of NSAIDs for the duration of trial

You may not qualify if:

  • concomitant use of anticoagulants;
  • a history of gastric or duodenal surgery other than a patch repair;
  • the presence of erosive esophagitis,
  • gastric outlet obstruction,
  • renal failure (defined by a serum creatinine level of more than 200 umol/L),
  • pregnancy,
  • terminal illness, or
  • cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoscopy Center, Prince of Wales Hospital

Shatin, Hong Kong, China

Location

Related Publications (1)

  • Chan FKL, Ching JYL, Tse YK, Lam K, Wong GLH, Ng SC, Lee V, Au KWL, Cheong PK, Suen BY, Chan H, Kee KM, Lo A, Wong VWS, Wu JCY, Kyaw MH. Gastrointestinal safety of celecoxib versus naproxen in patients with cardiothrombotic diseases and arthritis after upper gastrointestinal bleeding (CONCERN): an industry-independent, double-blind, double-dummy, randomised trial. Lancet. 2017 Jun 17;389(10087):2375-2382. doi: 10.1016/S0140-6736(17)30981-9. Epub 2017 Apr 11.

    PMID: 28410791DERIVED

MeSH Terms

Conditions

ArthritisCardiovascular DiseasesCerebrovascular Disorders

Interventions

CelecoxibNaproxen

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNaphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Francis K Chan, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

June 1, 2005

Primary Completion

November 1, 2014

Study Completion

December 1, 2016

Last Updated

January 2, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)