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

NCT01343303 | Completed Phase 1

• 2 other identifiers: CR01829239439335EDI1014
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis, knee; knee pain; pain measurement

Outcome Measures

Primary Outcomes (6)

• Number of participants with adverse events as a measure of safety and tolerability

  From screening up to final follow up visit.

• Change from baseline in vital signs, including oral body temperature

  From Day -1 up to final follow up visit

• Change from baseline in ECG

  From Day -1 up to final follow up visit

• Change from baseline in clinical laboratory tests

  From Day -1 up to final follow up visit

• Concentaton of JNJ-39439335 in blood and urine samples

  From Day 1 up to final follow up visit

• Concentration of JNJ-39439335 in blood and urine samples

  From Day 1 up to final follow up visit

Secondary Outcomes (2)

• Change from baseline in pain numerical rating scale

  From Day 2 up to final follow up visit

• Change from baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC)

  From Day -1 up to final follow up visit

Study Arms (4)

001

EXPERIMENTAL

JNJ-39439335 2 x 5 mg tablets once daily for 21 days

Drug: JNJ-39439335

002

EXPERIMENTAL

JNJ-39439335 2 x 25 mg tablets once daily for 21 days

Drug: JNJ-39439335

003

OTHER

Naproxen 500 mg capsule every 12 hours for 21 days

Drug: Naproxen

004

PLACEBO COMPARATOR

Placebo Placebo tablet/capsule every 12 hours for 21 days

Drug: Placebo

Interventions

Placebo DRUG

Placebo tablet/capsule every 12 hours for 21 days

004

JNJ-39439335 DRUG

2 x 25 mg tablets once daily for 21 days

002

Naproxen DRUG

500 mg capsule every 12 hours for 21 days

003

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

George, South Africa

Location

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

• Janssen Research & Development, LLC C. Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 28, 2011
• Study Start: March 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 9, 2012

Record last verified: 2012-08

Locations

ZA (1)