Safety and Efficacy of Etoricoxib 30 mg Versus Celecoxib 200 mg in Korean Participants With Osteoarthritis
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Etoricoxib 30 mg; Celecoxib 200 mg
Intervention description: Etoricoxib 30 mg tablet once daily for 12 weeks.; Celecoxib 200 mg once daily for 12 weeks
Intervention MeSH terms: Celecoxib; Etoricoxib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 239.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Celecoxib; Etoricoxib

Summary:

      The main purpose of this study is to establish that etoricoxib 30 mg is safe and not inferior
      to celecoxib 200 mg in the treatment of the signs and symptoms of osteoarthritis in Korean
      patients. Given that the efficacy of etoricoxib vs. placebo in the treatment of
      osteoarthritis has been established, and that prescription drugs, such as celecoxib, are
      available for the treatment of pain associated with osteoarthritis in Korea, it would be
      inappropriate to subject patients with a flare of osteoarthritic pain to the placebo
      treatment for 12 weeks, and thus the study is designed as an active-comparator study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is at least 40 years of age

          -  Clinical diagnosis of osteoarthritis of the knee for greater than 6 months based on
             clinical and radiographic criteria

          -  Female patients of childbearing potential must have a negative pregnancy test prior to
             study enrollment and must agree to remain abstinent, and use barrier, intramuscular,
             or implanted contraceptives from Visit 1 until 28 days after the last dose of study
             medication.

          -  Patient is of American Rheumatism Association (ARA) functional Class I, II, or III

          -  Patient is willing to limit alcohol intake to 2 or less drinks per day during study
             and the follow-up period

          -  Patient is willing to avoid unaccustomed physical activity for the duration of the
             study and follow-up period

          -  With the exception of osteoarthritis, the patient is judged to be in good general
             health based on medical history, physical exam, and routine laboratory tests

          -  Patient is able to read, understand and complete study questionnaires, including
             questions requiring a visual analog scale (VAS) response

          -  Patient provides written informed consent for the trial

          -  For prior non-steroidal anti-inflammatory drug (NSAID) users only, the patient has a
             history of positive therapeutic benefit with NSAIDs and has taken an NSAID prior to
             study enrollment and at a therapeutic dose level prior to study enrollment (Visit 1)

          -  For prior NSAID users only, the patient assessment of Pain Walking on a Flat Surface
             (WOMAC Section A, Question1) at Visit 1 (prestudy) is less than 80 mm (100 mm VAS)

          -  For prior NSAID users only, prior to randomization, and following discontinuation of
             NSAIDs during the washout period specified patients must satisfy the following 3 flare
             criteria: Minimum of 40 mm on patient reported Pain Walking on a Flat Surface (WOMAC
             Section A, Question 1); Increase of 15 mm on patient reported Pain Walking on a Flat
             Surface (WOMAC Section A, Question 1) compared to prestudy baseline recorded at Visit
             1; and A worsening in Investigator Global Assessment of Disease Status of at least 1
             category on a 5 category scale compared to Visit 1 recording

          -  For prior acetaminophen/paracetamol users only, patient has taken
             acetaminophen/paracetamol on a regular basis prior to study enrollment (Visit 1) and
             does not use NSAIDs for the treatment of osteoarthritis of the knee

          -  For prior acetominophen/paracetamol users only, at both Visits 1 and 2, patients must
             satisfy all of the following 3 criteria: Minimum of 40 mm on patient reported Pain
             Walking on a Flat Surface (WOMAC Section A, Question 1); Investigator Global
             Assessment of Disease Status as fair, poor, or very poor; and Minimum of 40 mm on
             Patient Global Assessment of Disease Status (100 mm

        VAS)

        Exclusion Criteria:

          -  Patient has a concurrent medical/arthritic disease that could confound or interfere
             with evaluation of efficacy

          -  Patient is legally incompetent (e.g., a minor or mentally incapacitated), or has
             active psychosis, or significant emotional problems at the time of the study which in
             the view of the investigator are sufficient to interfere with the conduct of the study

          -  Patient has a history of gastric or biliary surgery (including gastric bypass
             surgery), or small intestine surgery that causes clinical malabsorption

          -  Patient is allergic to, or has a history of a significant clinical or laboratory
             adverse experience associated with etoricoxib or celecoxib or any of their
             constituents

          -  Patient is allergic to acetaminophen/paracetamol, or has hypersensitivity (e.g.,
             bronchoconstriction in association with nasal polyps) to aspirin or NSAIDs

          -  Patient has an estimated glomerular filtration rate is less than or equal to 30 ml/min

          -  Patient has Class II-IV congestive heart failure

          -  Patient has established ischemic heart disease, cerebrovascular disease, or peripheral
             vascular disease

          -  Patient has uncontrolled hypertension with an diastolic exclusionary limit of > 90 mm
             Hg and a systolic exclusionary limit of > 140 mm Hg

          -  Patient has moderate or severe hepatic insufficiency defined as Child Pugh score > 6

          -  Patient has a history of neoplastic disease

          -  Patient has a history of any illness, which in the opinion of the investigator, might
             confound the results of the study or pose additional risk to the patient

          -  Patient is, at the time of signing informed consent, a user of recreational or illicit
             drugs or has had a recent history (within the last 5 years) of drug or alcohol abuse
             or dependence

          -  Patients considered morbidly obese with a body mass index (BMI) ≥ 35 kg/m^2

          -  Patient has new use (within 2 weeks of Visit 1 and during the entire duration of the
             study and follow-up period) of physical medicine modalities involving the study joint,
             including but not limited to: physical therapy, chiropractic interventions,
             acupuncture, Transcutaneous Electrical Nerve Stimulator (TENS), and ultrasound

          -  Patient is expected to undergo surgery involving the study joint during the course of
             the study

          -  Patients taking oral contraceptives

          -  Patients using intra-articular steroids or hyaluronic acid injections to the study
             knee or other immunosuppressant medication within 3 months of Visit 1

          -  Patients using intravenous, intramuscular, or oral corticosteroids, intra-articular
             steroids or hyaluronic acid injections to any joint other than the study joint within
             1 month of Visit 1

          -  Patients using topical or systemic analgesic medications within 3 days of Visit 1 and
             throughout the duration of the study

          -  Patients using non-study NSAID or cyclooxygenase 2 (COX-2) specific inhibitor during
             the study treatment period, with the exception of low-dose aspirin (≤ 325 mg/day)

          -  Patients receiving a Chinese traditional arthritis treatment within 1 week of Visit 1

          -  Patients with clinically significant abnormalities on Visit 1 clinical examination or
             laboratory safety tests. Serum transaminases should be ≤ 150% of the upper limit of
             normal

          -  Patients currently participating in or has participated in a study with an

        investigational drug or device within 4 weeks of signing informed consent

          -  Patients with an active peptic ulcer or a history of inflammatory bowel disease

          -  Patients with a personal or family history of an inherited or acquired bleeding

          -  Patients that are pregnant or breast-feeding, or expecting to conceive within the
             projected duration of the study