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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00933582
• Date of registration: 02/07/2009
• Prospective Registration: Yes
• Primary sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Public title: 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
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled Clinical Study of Single Doses of JNJ-39439335 Versus Single and Multiple Doses of Naproxen Versus Placebo in the Treatment of Painful Osteoarthritis of the Knee: Focus on Treatment Effects and Methodological Advances
• Date of first enrolment: August 2009
• Target sample size: 33
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00933582
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
• Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Osteoarthritis, Knee

Intervention(s)

Drug: JNJ-39439335; Placebo; Naproxen

Primary Outcome(s)

Sum of Pain Intensity Difference (SPID) for pain following exercise using a 0-10 numerical rating scale [Time Frame: At 4 hours after the in-clinic dosing on Days 1, 15, and 29, respectively]

Secondary Outcome(s)

Change from baseline in patient activity [Time Frame: on Days 1 to 7, 15 to 21, and 29 to 35]

2-hour postdose pain intensity difference (at rest, exercise-induced, and change from pre- to post-exercise) [Time Frame: on Days 1, 15, and 29]

4-hour postdose SPID (at rest and change from pre-to-post exercise) [Time Frame: on Days 1, 15, and 29]

Change from baseline in current pain numerical rating scale (NRS) [Time Frame: on Days 1, 15, and 29]

Change from predose WOMAC (the Western Ontario and McMaster Osteoarthritis Index) [Time Frame: On Days 1, 2, 7, 16, 21, 30, and 35]

Secondary ID(s)

CR016420

Source(s) of Monetary Support

Please refer to primary and secondary sponsors