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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Naproxen

Criteria

Inclusion Criteria:

• Patients with chronic osteoarthritis (OA) pain of the knee (on an average of at least 5 days per week for the 3 months prior to screening)

• Patients whose OA pain worsens with exercise

• Patients who have been taking a non-opioid pain medication for OA knee pain daily with benefit for at least 5 days over the week prior to screening

• Women must be postmenopausal or unable to have children

• Otherwise healthy

Exclusion Criteria:

• Patients with orthopedic and/or prosthetic device in the knee

• have significant pain that is not related to the knee, including significant hip or back pain that in the judgement of the investigator will interfere with pain measures at the knee (Patients with OA in both knees will be allowed into the study)

• Unable to discontinue all formulations of prior pain medications other than paracetamol during the study

• Unable to discontinue paracetamol for 12 hours prior to the clinic visits

• Patients with history of active peptic ulceration, active dyspepsia, gastrointestinal bleeding, Crohn's disease, ulcerative colitis, chronic diarrhea esophageal, and gastric or duodenal ulcer within 3 months prior to screening

• Patients who have had surgery for any chronic pain within 3 months prior to Screening or plans for surgery while in the study

• Patients with history of prior diagnosis of inflammatory arthritis including rheumatoid arthritis