Clinical trial: A Study of the Efficacy and Safety of 2PX in Patients With Pain Due to Osteoarthritis of the Knee (NCT00954629)

Eligibility criteria:
Inclusion Criteria:

          -  Male and female out-patients, 40 years or older.

          -  Subjects with documented OA of either one or both knees, as defined by the American
             College of Rheumatology (ACR) criteria ([Altman R, Asch E, Bloch D, et al (1986)]);
             i.e.knee pain and at least 3 out of the following 6 criteria in the target joint:

               -  age >50 years

               -  stiffness < 30 minutes

               -  crepitus

               -  bony tenderness

               -  bony enlargement

               -  no palpable warmth

          -  Radiological evidence of joint space narrowing in the target joint within 8 weeks
             prior to randomisation.

          -  Subjects with chronic, moderate to severe OA pain of the target knee:

               -  present for more than 3 months, and for ≥ 20 days per month.

               -  not controlled by, or intolerant of, oral NSAIDs, paracetamol, COX-2 inhibitors
                  or weak opioids.

               -  intensity at least moderate (i.e., actual WOMAC (pain questions 1-5) ≥ 10) on
                  WOMAC OA index LK 3.1 at Visit 1, in the target knee, as recalled over the last
                  24 hours.

        Exclusion Criteria:

          -  Subjects with any moderate to severe pain of other origin (e.g., fibromyalgia) which
             could confound assessment or self-evaluation of pain due to OA in the target knee.

          -  Subjects with any prosthesis fitted to the target knee.

          -  Subjects requiring treatment with any of the following agents/therapies within the
             specified periods or at any time during the study are excluded from participation:

          -  Any potent/strong opioid in the 4 weeks prior to randomisation (i.e., an opioid
             assumed to cause withdrawal symptoms upon abrupt discontinuation).

          -  Any topical or subcutaneously applied analgesic agents (e.g., capsaicin, NSAIDs)
             applied to the target knee within 7 days prior to randomisation.

          -  Any treatment which could alter the degree or nature of baseline OA pain planned
             within the study period.

          -  Intra-articular injections of corticosteroids in the target knee within the 2 months
             prior to randomisation.

          -  Intra-articular injections of hyaluronan in the target knee within 6 months prior to
             randomisation.

          -  Avascular necrosis in the target knee within 6 months prior to randomisation.

          -  Arthrosynthesis of the target knee within 12 months prior to randomisation.

          -  Arthroscopy of the target knee within 6 months prior to randomisation.

          -  Major trauma to the target knee within 6 months prior to randomisation.

          -  Infection in the target knee within 6 months prior to randomisation.

          -  Subjects who have previously been treated with 2PX.

          -  Subjects who have received an investigational drug or used an investigational device
             within the 30 days prior to randomisation.

          -  Subjects with a significant psychiatric disorder, in the opinion of the investigator,
             or subjects receiving strong anti-psychotic medication.

          -  Subjects with documented or suspected alcohol or drug abuse.

          -  Any ongoing or past history of malignant disease within the 5 years immediately prior
             to randomisation (with the exception of basal cell carcinoma).

          -  Pregnancy or ongoing lactation

          -  Female subjects of childbearing potential unwilling to use adequate contraceptive
             measures throughout the duration of the study. For the purpose of this study, adequate
             contraception is defined as:

               -  oral, injected or implanted hormonal methods of contraception; OR

               -  placement of an intrauterine device (IUD) or intrauterine system (IUS); OR

               -  barrier methods of contraception: Condom or occlusive cap (diaphragm or
                  cervical/vault caps) with spermicidal foam/gel/film/cream/suppository Note: Male
                  sterilisation or abstinence are not acceptable methods of birth control and would
                  preclude enrolment in the study.

        Note: For post-menopausal women: less than 12 months since the last spontaneous menstrual
        bleeding will exclude the patient unless they are willing to utilise acceptable methods of
        contraception for the duration of the study.

          -  Male subjects able to conceive, who are unwilling to use barrier methods of
             contraception throughout the duration of the study

          -  Subjects unable to comply with the study assessments.
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.


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? 1