Clinical trial: Efficacy of Celecoxib 200mg in Relieving Pain and Walking Dysfunction in Osteoarthritis of the Knee (NCT00597415)

Eligibility criteria:
Inclusion Criteria:

          -  If female and of childbearing potential, must be using adequate contraception since
             last menses and will use adequate contraception during the study,

          -  Diagnosed as having OA of the knee

          -  Functional Capacity Classification of I-II (FCC)

          -  If on active analgesic or anti-inflammatory pain medication, must have VAS pain
             score>=30mm in signal knee related to walking on a flat surface within the previous 48
             hours. Subjects who are not taking any pain medication must have a VAS pain
             score>=40mm in the signal knee

          -  At baseline visit, must have a history of pain in the signal knee>=40mm when walking
             on the flat within the previous 48 hours.

          -  In the Investigator's opinion, the patient requires and is eligible for therapy with
             an anti-inflammatory analgesic.

          -  If on an NSAID or analgesic, patient must have completed a washout period prior to
             baseline assessments that is a minium of five half lives.

          -  The patient has provided written informed consent before undergoing any study
             procedures.

        Exclusion Criteria:

          -  Diagnosed as having inflammatory arthritis or acute trauma at the index joint.

          -  Another painful condition that would interfere with his/her ability to walk or to make
             reasonable assessments of their pain.

          -  Received an injection of corticosteroid into the signal knee within 3 months; or with
             a hyaluronan produce in the signal knee within the previous 6 months.

          -  Requires the use of a cane or other assistive device to complete the walk.

          -  Known cardiovascular disease which has been symptomatic in the past 12 months

          -  History of blood clots or is at any increased risk for blood clotting.

          -  Asthma or any breathing condition which would preclude walking briskly for 20
             consecutive minutes or 40 minutes total.

          -  Has taken any NSAIDs, COX-2 inhibitors, or any analgesic, with the exception of the
             rescue acetaminophen, within two days prior to Visit 2

          -  Active malignancies or any type or a malignancy that has recurred within 5 years
             before enrollment.

          -  Diagnosed as having or has been treated for esophageal, gastric, pyloric channel,
             duodenal ulceration within 90 days

          -  Active GI disease, a chronic or acute renal or hepatic disorder, or a significant
             coagulation defect.

          -  Any chronic illness or laboratory abnormalities considered to be clinically
             significant.

          -  Received any investigational medication within 30 days

          -  Known hypersensitivity to celecoxib, NSAIDs, to sulfonamides

          -  Use of the following drugs:

               1. NSAIDs or COX-2 specific inhibitors

               2. Analgesics except rescue medication within 24 hours of a study visit

               3. Anticoagulants

               4. Lithium

               5. Glucosamine or chondroitin sulfate are excluded unless on stable dose for at
                  least 3 months
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment