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

NCT00933582 | Completed Phase 1

• 1 other identifier: CR016420
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis, Knee; Knee Pain; Pain Measurement; Naproxen; Placebo; Treatment Outcome

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Difference (SPID) for pain following exercise using a 0-10 numerical rating scale

  At 4 hours after the in-clinic dosing on Days 1, 15, and 29, respectively

Secondary Outcomes (5)

• 2-hour postdose pain intensity difference (at rest, exercise-induced, and change from pre- to post-exercise)

  on Days 1, 15, and 29

• 4-hour postdose SPID (at rest and change from pre-to-post exercise)

  on Days 1, 15, and 29

• Change from predose WOMAC (the Western Ontario and McMaster Osteoarthritis Index)

  On Days 1, 2, 7, 16, 21, 30, and 35

• Change from baseline in current pain numerical rating scale (NRS)

  on Days 1, 15, and 29

• Change from baseline in patient activity

  on Days 1 to 7, 15 to 21, and 29 to 35

Interventions

JNJ-39439335; Placebo; Naproxen DRUG

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

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

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 7, 2009
• Study Start: August 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 2, 2010

Record last verified: 2010-07