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

Last updated on May 11, 2018

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Study Location
Pfizer Investigational Site
Genk, , 3600 Belgium
Contact
1-800-718-1021
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.

NCT00141102
Pfizer
Completed
Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis

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Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Osteoarthritis
  • Arthritis, Rheumatoid
  • 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
  • Experimental: A
    Intervention: Drug: Celecoxib
  • Active Comparator: B
    Intervention: Drug: Diclofenac + Omeprazole


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4484
May 2009
May 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
Former Serbia and Montenegro,   Ireland
 
NCT00141102
A3191084
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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