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

NCT01343303 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2012-08-09

No results posted yet for this study

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

Interventions

DRUG

Placebo

Placebo tablet/capsule every 12 hours for 21 days

DRUG

JNJ-39439335

2 x 25 mg tablets once daily for 21 days

DRUG

Naproxen

500 mg capsule every 12 hours for 21 days

DRUG

JNJ-39439335

2 x 5 mg tablets once daily for 21 days

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC C. Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Completion
2011-12-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01343303 on ClinicalTrials.gov