NCT00153673

Brief Summary

The purpose of this study is to compare the effect of Famotidine plus a COX-2 inhibitor (celecoxib) with Famotidine plus dologesics in ulcer healing in arthritis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2001

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

February 1, 2001

Completed
4.6 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
11.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2017

Completed
Last Updated

April 21, 2017

Status Verified

April 1, 2017

Enrollment Period

15.9 years

First QC Date

September 8, 2005

Last Update Submit

April 20, 2017

Conditions

ArthritisGastric Ulcer

Keywords

celecoxibarthritisulcer healing

Outcome Measures

Primary Outcomes (1)

  • ulcer healing

    8 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Celecoxib + Famotidine

Drug: celecoxib

2

ACTIVE COMPARATOR

Dologesics + Famotidine

Drug: Dologesics

Interventions

celecoxibDRUG

Celecoxib 200mg bd

1
DologesicsDRUG

Dologesics 2 tablets bd

2

Eligibility Criteria

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

You may qualify if:

  • Gastric ulcers confirmed by endoscopy
  • Stop taking NSAIDs for 1 week prior to endoscopy
  • Age 18
  • H. pylori negative
  • Informed written consent

You may not qualify if:

  • Actively bleeding ulcers
  • Ulcers showing dysplasia or malignancy
  • Renal failure (serum creatinine \>200umol/l)
  • Previous gastric surgery
  • Moribund or terminal malignancy
  • Concomitant use of proton pump inhibitor, misoprostol, aspirin, steroid or anticoagulant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoscopy Center, Prince of Wales Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

ArthritisStomach Ulcer

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPeptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic 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 8, 2005

First Posted

September 12, 2005

Study Start

February 1, 2001

Primary Completion

December 28, 2016

Study Completion

April 12, 2017

Last Updated

April 21, 2017

Record last verified: 2017-04

Locations

CN(1)