Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis

NCT00141102

Last updated date
Study Location
Pfizer Investigational Site
Genk, , 3600, Belgium
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis, Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects with a clinical diagnosis of OA or RA and who are expected to require regular anti-inflammatory therapy for arthritis symptom management

- Subjects must be aged 60 years or older with or without a history of gastroduodenal (GD) ulceration; or be of any age 18 years or older and have had documented evidence of GD ulceration 90 days or more prior to the screening visit

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Active GD ulceration or GD ulceration within 90 days of the screening visit.


- Concomitant use of low dose aspirin


- Previous MI, stroke or significant vascular disease.

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Osteoarthritis, Rheumatoid ArthritisStudy Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis
NCT00141102
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MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis
Official Title  ICMJE Double-Blind, Triple Dummy, Parallel-Group, Randomized, Six-Month Study To Compare Celecoxib (200 Mg BID) With Diclofenac Sr (75 Mg BID) Plus Omeprazole (20 Mg QD) For Gastrointestinal Events In Subjects With Osteoarthritis And Rheumatoid Arthritis At High-Risk Of Gastrointestinal Adverse Events
Brief Summary To determine whether celecoxib is superior to combined therapy with diclofenac and omeprazole in the incidence of clinically significant upper and/or lower gastrointestinal (GI) events in high GI risk subjects with osteoarthritis and/or rheumatoid arthritis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis
  • Arthritis, Rheumatoid
Intervention  ICMJE
  • Drug: Celecoxib
    Participants are assigned to one of two groups in parallel for the duration of the study
  • Drug: Diclofenac + Omeprazole
    Participants are assigned to one of two groups in parallel for the duration of the study
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Celecoxib
  • Active Comparator: B
    Intervention: Drug: Diclofenac + Omeprazole
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2010)
4484
Original Enrollment  ICMJE
 (submitted: August 31, 2005)
4400
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with a clinical diagnosis of OA or RA and who are expected to require regular anti-inflammatory therapy for arthritis symptom management
  • Subjects must be aged 60 years or older with or without a history of gastroduodenal (GD) ulceration; or be of any age 18 years or older and have had documented evidence of GD ulceration 90 days or more prior to the screening visit

Exclusion Criteria:

  • Active GD ulceration or GD ulceration within 90 days of the screening visit.
  • Concomitant use of low dose aspirin
  • Previous MI, stroke or significant vascular disease.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Brazil,   Canada,   China,   Colombia,   Costa Rica,   Croatia,   Czech Republic,   Ecuador,   Estonia,   France,   Germany,   Greece,   Guatemala,   Hong Kong,   India,   Korea, Republic of,   Latvia,   Lithuania,   Netherlands,   Panama,   Peru,   Portugal,   Russian Federation,   Serbia,   Singapore,   South Africa,   Spain,   Sweden,   Taiwan,   Ukraine,   United Kingdom
Removed Location Countries Former Serbia and Montenegro,   Ireland
 
Administrative Information
NCT Number  ICMJE NCT00141102
Other Study ID Numbers  ICMJE A3191084
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP