A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-39439335 in Patients With Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01343303
First received: April 7, 2011
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to evaluate the safety of multiple oral doses of JNJ-39439335 and to assess how JNJ-39439335 is absorbed (taken in), distributed, metabolized (broken down), and eliminated from the body (referred to as pharmacokinetics) in osteoarthritis patients. This study will also assess the effectiveness of JNJ-39439335 on pain.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-and Active-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-39439335 in Subjects With Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: From screening up to final follow up visit. ] [ Designated as safety issue: Yes ]
  • Change from baseline in vital signs, including oral body temperature [ Time Frame: From Day -1 up to final follow up visit ] [ Designated as safety issue: Yes ]
  • Change from baseline in ECG [ Time Frame: From Day -1 up to final follow up visit ] [ Designated as safety issue: Yes ]
  • Change from baseline in clinical laboratory tests [ Time Frame: From Day -1 up to final follow up visit ] [ Designated as safety issue: Yes ]
  • Concentaton of JNJ-39439335 in blood and urine samples [ Time Frame: From Day 1 up to final follow up visit ] [ Designated as safety issue: No ]
  • Concentration of JNJ-39439335 in blood and urine samples [ Time Frame: From Day 1 up to final follow up visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in pain numerical rating scale [ Time Frame: From Day 2 up to final follow up visit ] [ Designated as safety issue: No ]
  • Change from baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) [ Time Frame: From Day -1 up to final follow up visit ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: March 2011
Study Completion Date: December 2011
Arms Assigned Interventions
Experimental: 001
JNJ-39439335 2 x 5 mg tablets once daily for 21 days
Drug: JNJ-39439335
2 x 5 mg tablets once daily for 21 days
Experimental: 002
JNJ-39439335 2 x 25 mg tablets once daily for 21 days
Drug: JNJ-39439335
2 x 25 mg tablets once daily for 21 days
003
Naproxen 500 mg capsule every 12 hours for 21 days
Drug: Naproxen
500 mg capsule every 12 hours for 21 days
Placebo Comparator: 004
Placebo Placebo tablet/capsule every 12 hours for 21 days
Drug: Placebo
Placebo tablet/capsule every 12 hours for 21 days

Detailed Description:

This will be a double-blind (patient and study staff will not know the identity of assigned treatment), randomized (assignment to 1 to 3 treatment groups will be by chance, like "flipping a coin"), placebo-controlled, multiple dose study conducted at up to two clinical sites. Up to 42 patients with osteoarthritis of the knee will be enrolled in 3 cohorts (Cohort 1 to 3). Additional cohorts (up to 14 patients per cohort) may be added after completion of Cohort 3. The study consists of eligibility screening, a treatment phase, and 4 follow-up visits. The study duration for each patient will be approximately 10 weeks. Patients safety will be closely monitored during the study by review of adverse events, electrocardiograms, vital signs (including oral temperature), clinical laboratory tests, and physical examinations. During specified study visits, blood samples will be collected for pharmacokinetics, pharmacodynamics (inpatient patients), and pharmacogenomic (optional) evaluations of JNJ-39439335. The effectiveness of JNJ-39439335 will be evaluated by assessing pain using an 11-point numerical rating scale and by the Western Ontario and McMaster Osteoarthritis Index. In Cohort 1 and 2, all patients will take their study medication orally, twice a day for 21 days. The treatment groups for Cohort 1 are JNJ-39439335 10 mg, naproxen 500 mg every 12 hours, and placebo. The treatment groups for Cohort 2 are JNJ-39439335 25 mg, naproxen 500 mg every 12 hours, and placebo. The treatment groups for Cohort 3 will be determined based on the results of Cohort 1 and 2.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Nonsmoker >= 6 months prior to first dose
  • body mass index (BMI) <= 36 kg/m2
  • Meet American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of knee by meeting at least 3 of the following: age > 50, morning stiffness < 30 minutes, crepitus on active motion, bony tenderness, bony enlargement, no palpable warmth of synovium
  • Has Functional Class I-III osteoarthritis (OA) of knee with continuing OA-knee joint pain >= 5 days/week x 3 months prior to screening, and has been taking a non-opioid analgesic for OA knee pain daily for >=5 days prior to screening with benefit
  • Otherwise healthy based on physical exam, medical history, vital signs, 12-lead electrocardiogram (ECG), can clinical laboratory tests
  • Women must be postmenopausal or surgically sterile.

Exclusion Criteria:

  • Oral temperature >37.5 deg C at Screening or Day -1
  • Failure of burn prevention measures quiz at Screening
  • patients with occupations or hobbies in which they are routinely exposed to situations in which they could sustain burns
  • orthopedic and/or prosthetic device on target knee joint
  • Significant pain outside the target knee, including significant hip or back pain (bilateral knee OA is permitted)
  • Unable to discontinue prior analgesic medications/non-steroidal antiinflammatory drugs (NSAIDS) other than paracetamol during the study
  • Surgical intervention for any pain within 3 months prior to screening or has plans for surgical intervention while in the study
  • History of prior diagnosis of inflammatory arthritis (including rheumatoid arthritis)
  • Treatment with local corticosteroid injections or viscosupplementation in target joint, or use of oral or intramuscular corticosteroids, within 3 months prior to Screening
  • 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 or any other condition, which in the Investigator's opinion, precludes use of an NSAID.
  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: NCT01343303

Locations
South Africa
George, South Africa
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC C. Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Senior Director, Clinical R&D, Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01343303     History of Changes
Other Study ID Numbers: CR018292, 39439335EDI1014
Study First Received: April 7, 2011
Last Updated: August 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Janssen Research & Development, LLC:
Osteoarthritis, knee
knee pain
pain measurement

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 22, 2014