A Clinical Study to Investigate the Effect on Pain Relief of a Single Dose of JNJ-39439335 in Patients With Chronic Osteoarthritis Pain of the Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this single-center study is to evaluate the potential analgesic effects of a
      single oral dose (50 mg) of JNJ-39439335, an investigational drug being developed for the
      treatment of pain in patients with chronic osteoarthritis pain of the knee. The study will
      also evaluate the pain treatment response assessments and methods being used in this study.
      Participants will also take naproxen (500 mg) and placebo (an inactive substance) during the
      study. Pain assessments after taking JNJ-39439335, naproxen and placebo will be compared.
    

Detailed description: 
      The purpose of this single-center study is to evaluate the potential analgesic effects of a
      single oral dose of JNJ-39439335 (50 mg), an investigational drug being developed for the
      treatment of pain, in patients with chronic osteoarthritis pain of the knee. The study will
      also evaluate the pain treatment response assessments and methods being used in this study.
      Naproxen (500 mg) will be used as the active control. The hypothesis of the study is that a
      single 50 mg oral dose of JNJ-39439335 will be superior to placebo in relieving pain in
      patients with osteoarthritis knee pain following exercise. Patients will receive JNJ-39439335
      , placebo (an inactive substance, like a sugar pill), or naproxen (500 mg) in the clinic on
      Days 1, 15, and 29, based on the randomly assigned (like flipping a coin) treatment sequence.
      Patients will stay in the clinic for pain assessments up to 4 hours post-dose. At 6 hours
      post-dose, patients will be discharged from the clinic. Patients will then take naproxen (500
      mg) or matching placebo at 12 hours post-dose and continue taking naproxen (500 mg) or
      matching placebo every 12 hours for the following 6 days. During the study, starting from the
      first screening visit, patients will be required to discontinue all pain medication and will
      be encouraged not to take any rescue medication (quick-relief or fast-acting medications that
      work immediately to relieve pain), especially during the dosing periods, for up to 6 days
      after each in-clinic study drug dosing on Day 1, Day 15, and Day 29, respectively. When
      needed, patients may take paracetamol (500 mg per dose for up to a maximum of 2 grams per
      day) as rescue medication; however, patients are required not to take any rescue medication
      starting from 12 hours before through 6 hours after the in-clinic dosing on Day 1, Day 15,
      and Day 29, respectively. Patients' pain will be evaluated for each of the 3 treatments.
      Safety assessments, including vital signs, physical exams, electrocardiograms and clinical
      lab tests will be performed at timepoints throughout the patients' study participation.
      Patients will receive JNJ-39439335 (50 mg), placebo, or naproxen (500 mg) oral tablets on
      Days 1, 15, and 29, based on the assigned treatment sequence. At 12 hours postdose, patients
      in the naproxen treatment arm will start self-administering naproxen (500 mg) twice daily for
      6 days while patients in the placebo or the JNJ-39439335 treatment arm will take placebo
      twice daily for 6 days.
    

Intervention name(s): JNJ-39439335; Placebo; Naproxen
Intervention type(s): Drug
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis, Knee; Knee Pain; Pain Measurement; Naproxen; Placebo; Treatment Outcome