A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108)

Status:	Completed
Conditions:	Arthritis, Neurology
Therapuetic Areas:	Neurology, Rheumatology
Healthy:	No
Age Range:	18 - Any
Updated:	5/3/2014
Start Date:	September 2010
End Date:	March 2015
Contact:	Toll Free Number
Phone:	1-888-577-8839

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

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 evaluate the improvement in Spinal Pain Intensity over 6 weeks of
treatment with etoricoxib 90 mg or 60 mg compared to naproxen; and to evaluate the
improvement in Spinal Pain Intensity over 6 weeks of treatment with etoricoxib 90 mg
compared with etoricoxib 60 mg. Additionally the added benefit of increasing the dose of
etoricoxib from 60 mg to 90 mg will be assessed in the second part of the study.

Inclusion Criteria:

- 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 Criteria:

- 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 has 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 (cancer or benign tumor), 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

We found this trial at

sites

Clinical Trial Facility in Fayetteville Georgia

Fayetteville, Georgia 30214

from

Fayetteville, GA