CTRI/2011/07/001927CompletedPhase 3
A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients With Ankylosing Spondylitis - Nil
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp Dohme Corp
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •There is no maximum age limit.
- •- Has a definite diagnosis of Ankylosing Spondylitis (AS) 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
- •- 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 Criteria
- •- Has inflammatory arthritis (eg, rheumatoid arthritis, psoriatic arthritis, crystal-induced arthritis,
- •spondyloarthropathy, diffuse idiopathic skeletal hyperostosis [DISH]), polymyalgia rhuematica, a history of septic arthritis or intra-articular fracture of the study joint, Wilsons 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 active peptic ulcer or a 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 (cancer or benign tumor), except adequately treated basal cell carcinoma or carcinoma in situ of the cervix, or malignancies that have been successfully treated greater than or equal to 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.
Investigators
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