Clinical trial: Efficacy and Safety Study of PG201 Tablet in Patients With Osteoarthritis (NCT01122485)

Eligibility criteria:
Inclusion Criteria:

          -  Patients ≥40 and ≤ 75 years of age

          -  For a woman, she should meet one of the following criteria to be eligible for the
             study: i) A woman of no childbearing potential ii) As for a woman of childbearing
             potential, she should have a negative pregnancy test result at screening and
             baseline/randomization

          -  Patients should be able and willing to provide the written informed consent.

          -  Patients should be able to read and understand the information provided for the study
             and be able to record the information requested by the study.

          -  Patients who meet the American College of Rheumatology clinical plus radiographic
             classification criteria for idiopathic osteoarthritis of the knee, which are defined
             as follow: a patient who had knee pain and radiographically diagnosed osteophytes and
             met at least one of the followings. i) Age> 50 years ii) Morning stiffness for less
             than 30 minutes iii) Crepitus during movement of the weight-bearing knee

          -  Patients with symptomatic primary osteoarthritis of the knee at least in the last 3
             months prior to screening.

          -  Patients with severity of grade 2 or 3 according to Kellgren & Lawrence scale based on
             anteroposterior radiographic evidence of the tibiofemoral joints with osteoarthritis,
             and who are classified in functional class of I, II or III according to the American
             Rheumatism Association functional classification.

          -  Patients who had a score of the Western Ontario and McMaster Universities
             Osteoarthritis Index (WOMAC) pain subscale question 1 ≤80 mm at screening, a score of
             the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain
             subscale question 1 ≥50 mm at baseline. a decrease in the score of the Western Ontario
             and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale question 1 at
             least by 15mm from screening to baseline and a decrease in the patient self-assessed
             arthritis symptoms scores at least by one point from screening to baseline.

          -  Patients who received Nonsteroidal antiinflammatory drugs (NSAIDs)/Cyclooxygenase-2
             inhibitor for the treatment of arthritis of the knee for at least 5 days a week during
             4 weeks prior to screening

        Exclusion Criteria:

          -  Patients with a known hypersensitivity or intolerance to Nonsteroidal antiinflammatory
             drugs (NSAIDs), aspirin or Cyclooxygenase-2 inhibitor.

          -  Patients with a clinical or biochemical abnormal finding (excluding any finding
             related to the investigating disease) at the screening visit, which in the
             investigator's opinion was considered to be clinically significant or might make safe
             participation in the study more difficult

          -  Patients with a history of gastroduodenal perforation and/or occlusion, gastric or
             duodenal surgery, progressive upper gastrointestinal ulcer within the last 6 months or
             a history of upper gastrointestinal bleeding (including hematemesis) within the last
             one year, lower gastrointestinal bleeding within the last one year (excluding
             hemorrhoid), inflammatory intestinal disease within the last 6 months, coronary artery
             disease, congestive heart failure or renal artery stenosis, stroke or transient
             ischemic attack.

          -  Patients with uncontrollable hypertension

          -  Patients receiving aspirin therapy (low-dose aspirin in a daily dose of 325mg or less
             is permitted for prevention of cardiovascular disease).

          -  Patients receiving anticoagulant drug or antiplatelet drug (excluding low-dose
             aspirin) or who have a disease associated with hemostatic disorder.

          -  Patients with any of creatinine, bilirubin, Alanine aminotransferase or Aspartate
             aminotransferase > 1.5 times the Upper Lange of normal at screening. Patients who have
             any two or more of bilirubin, Alanine aminotransferase or Aspartate aminotransferase
             level greater than the Upper Lange of normal will also be excluded.

          -  Patients with a history of drug or alcohol abuse.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough.  Her other medical problems include hypertension, dyslipidemia, and osteoarthritis.  She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg.  The patient's breath smells bad. Other physical examinations are normal.  A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus.

Patient description (patient's own words): I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus.

Does the patient match the trial criteria? 1