Status:
COMPLETED
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
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
21-65 years
Phase:
PHASE1
Brief 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 ...
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00933582
Start Date
August 1 2009
End Date
June 1 2010
Last Update
August 2 2010
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.