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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00933582
First received: July 2, 2009
Last updated: July 29, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Osteoarthritis, Knee
Drug: JNJ-39439335; Placebo; Naproxen
Phase 1

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
Official 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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 4-hour postdose SPID (at rest and change from pre-to-post exercise) [ Time Frame: on Days 1, 15, and 29 ] [ Designated as safety issue: No ]
  • Change from predose WOMAC (the Western Ontario and McMaster Osteoarthritis Index) [ Time Frame: On Days 1, 2, 7, 16, 21, 30, and 35 ] [ Designated as safety issue: No ]
  • Change from baseline in current pain numerical rating scale (NRS) [ Time Frame: on Days 1, 15, and 29 ] [ Designated as safety issue: No ]
  • Change from baseline in patient activity [ Time Frame: on Days 1 to 7, 15 to 21, and 29 to 35 ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: August 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933582

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Associate Director Early Development
ClinicalTrials.gov Identifier: NCT00933582     History of Changes
Other Study ID Numbers: CR016420
Study First Received: July 2, 2009
Last Updated: July 29, 2010
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Osteoarthritis, Knee
Knee Pain
Pain Measurement
Naproxen
Placebo
Treatment Outcome

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014