Back to results

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

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Phase 1

Locations

South Africa

Study Type

Interventional

Intervention

Placebo

JNJ-39439335

Naproxen

JNJ-39439335

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, knee, knee pain, pain measurement

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Other

Placebo Comparator

Arm Label

001

002

003

004

Arm Description

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

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

Naproxen 500 mg capsule every 12 hours for 21 days

Placebo Placebo tablet/capsule every 12 hours for 21 days

Outcomes

Primary Outcome Measures

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

Change from baseline in vital signs, including oral body temperature

Change from baseline in ECG

Change from baseline in clinical laboratory tests

Concentaton of JNJ-39439335 in blood and urine samples

Concentration of JNJ-39439335 in blood and urine samples

Secondary Outcome Measures

Change from baseline in pain numerical rating scale

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

Full Information

NCT ID

NCT01343303

First Posted

April 7, 2011

Last Updated

August 8, 2012

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT01343303

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

Keywords

Osteoarthritis, knee, knee pain, pain measurement

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

001

Arm Type

Experimental

Arm Description

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

Arm Title

002

Arm Type

Experimental

Arm Description

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

Arm Title

003

Arm Type

Other

Arm Description

Naproxen 500 mg capsule every 12 hours for 21 days

Arm Title

004

Arm Type

Placebo Comparator

Arm Description

Placebo Placebo tablet/capsule every 12 hours for 21 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo tablet/capsule every 12 hours for 21 days

Intervention Type

Drug

Intervention Name(s)

JNJ-39439335

Intervention Description

2 x 25 mg tablets once daily for 21 days

Intervention Type

Drug

Intervention Name(s)

Naproxen

Intervention Description

500 mg capsule every 12 hours for 21 days

Intervention Type

Drug

Intervention Name(s)

JNJ-39439335

Intervention Description

2 x 5 mg tablets once daily for 21 days

Primary Outcome Measure Information:

Title

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

Time Frame

From screening up to final follow up visit.

Title

Change from baseline in vital signs, including oral body temperature

Time Frame

From Day -1 up to final follow up visit

Title

Change from baseline in ECG

Time Frame

From Day -1 up to final follow up visit

Title

Change from baseline in clinical laboratory tests

Time Frame

From Day -1 up to final follow up visit

Title

Concentaton of JNJ-39439335 in blood and urine samples

Time Frame

From Day 1 up to final follow up visit

Title

Concentration of JNJ-39439335 in blood and urine samples

Time Frame

From Day 1 up to final follow up visit

Secondary Outcome Measure Information:

Title

Change from baseline in pain numerical rating scale

Time Frame

From Day 2 up to final follow up visit

Title

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

Time Frame

From Day -1 up to final follow up visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Research & Development, LLC C. Clinical Trial

Organizational Affiliation

Janssen Research & Development, LLC

Official's Role

Study Director

Facility Information:

City

George

Country

South Africa

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs