Not Signed In -
Diclofenac |
Voltaren |
Clinical Trial: Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis
This study is not yet open for patient recruitment.
Verified by Pfizer August 2005
|
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Osteoarthritis Arthritis, Rheumatoid | Drug: Celecoxib Drug: Diclofenac plus Omeprazole | Phase IV |
MedlinePlus related topics: Osteoarthritis; Rheumatoid Arthritis
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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
Further Study Details:
Primary Outcomes: The primary endpoint of this study is the incidence of clinically significant upper and/or lower GI events (CSULGIEs). For the purposes of this trial CSULGIEs are considered any event that in clinical practice would impact the subject in terms of inpatie
Secondary Outcomes: The secondary endpoints of this study are:; The incidence of CSULGIEs plus symptomatic ulcers (SUs); The Patients Global Assessment of Arthritis; Change in Hb and Hct from Baseline to Visit 6; The incidence of subjects who have a clinically significant d
Expected Total Enrollment: 4400
Secondary Outcomes: The secondary endpoints of this study are:; The incidence of CSULGIEs plus symptomatic ulcers (SUs); The Patients Global Assessment of Arthritis; Change in Hb and Hct from Baseline to Visit 6; The incidence of subjects who have a clinically significant d
Expected Total Enrollment: 4400
Study start: October 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
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.
- Concommitant use of low dose aspirin
- Previous MI, stroke or significant vascular disease.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00141102
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A3191084
Last Updated: August 31, 2005
Record first received: August 29, 2005
ClinicalTrials.gov Identifier: NCT00141102
Health Authority: United Kingdom: Department of Health
ClinicalTrials.gov processed this record on 2005-09-06
Last Updated: August 31, 2005
Record first received: August 29, 2005
ClinicalTrials.gov Identifier: NCT00141102
Health Authority: United Kingdom: Department of Health
ClinicalTrials.gov processed this record on 2005-09-06
Resources
- Diclofenac (Drug Digest)
- Voltaren (Drug Digest)
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