Status:
COMPLETED
A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108)
Lead Sponsor:
Organon and Co
Conditions:
Spondylitis, Ankylosing
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the efficacy and tolerability of two doses of etoricoxib compared to naproxen in the treatment of ankylosing spondylitis (AS). The primary objectives are to eva...
Eligibility Criteria
Inclusion
- Has a definite diagnosis of Ankylosing Spondylitis (AS) per Modified New York Criteria made at least 6 months prior to screening
- Has a history of positive therapeutic benefit with non-steroidal anti-inflammatory drugs (NSAIDs) and regular use of NSAIDS for past 30 days
- Has a score on Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 at screening visit that is \<77 mm
- Must demonstrate sufficient "flare" or worsening of AS pain
- Is in general good health (other than AS)
- Has had approved non-study antirheumatic therapy that has been at stable dosing AND is not anticipated to undergo a change within the first 6 weeks of the protocol
Exclusion
- Has inflammatory arthritis (eg, rheumatoid arthritis, psoriatic arthritis, crystal-induced arthritis, spondyloarthropathy, diffuse idiopathic skeletal hyperostosis \[DISH\]), polymyalgia rheumatica, a history of septic arthritis or intra-articular fracture of the study joint, Wilson's disease, hemachromatosis, ochronosis, or primary osteochondromatosis
- Has acute peripheral articular disease (onset within 4 weeks prior to screening) of an active (painful or swollen) peripheral arthritis
- Has a history of gastric or biliary surgery, or small intestine surgery that causes clinical malabsorption
- Has had an active peptic (gastric or duodenal) ulcer or history of inflammatory bowel disease
- Has undergone coronary artery bypass graft surgery (CABG), angioplasty, or has a cerebrovascular accident or transient ischemic attack within the past 6 months or has active ischemic heart disease, cerebrovascular disease, or peripheral vascular disease
- Has Class II-IV congestive heart failure
- Has uncontrolled hypertension
- Has a history of neoplastic disease, except adequately treated basal cell carcinoma or carcinoma in situ of the cervix, or malignancies that have been successfully treated ≥ 5 years prior to screening
- Has history of leukemia, lymphoma, malignant melanoma, and myeloproliferative disease
- Allergy to etoricoxib or naproxen, or history of a significant clinical or laboratory adverse experience associated with etoricoxib or naproxen
- Has a history or family history of an inherited or acquired bleeding disorder
- Is considered morbidly obese and demonstrates significant health problems stemming from obesity, which would confound study participation or interpretation of study results
- Is pregnant, breast-feeding, or expecting to conceive during the study
- Has a clinical diagnosis of hepatic insufficiency defined as Child-Pugh score ≥ 5
Key Trial Info
Start Date :
September 27 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2014
Estimated Enrollment :
1015 Patients enrolled
Trial Details
Trial ID
NCT01208207
Start Date
September 27 2010
End Date
November 12 2014
Last Update
June 18 2024
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