Recent Updates
Recently added Catalysts

JNJ-39439335

Phase 1

Osteoarthritis, Knee | Small molecule | Musculoskeletal |Johnson & Johnson|Trials Updated: Aug 9, 2012

JNJ-39439335 development status

Highest phase Phase 1
Registered trials 3 across 2 sponsors since Nov 2009

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment55

FDA Designations

No designations recorded

JNJ-39439335 clinical trials

JNJ-39439335 · 2 trials · 2 indications

Phase 1 2
NCT01343303A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-39439335 in Patients With OsteoarthritisOsteoarthritis, Knee
COMPLETED43 Analytics
NCT01006304An Exploratory Study to Assess the Effects of JNJ-39439335 on the Relief of Pain Using a Thermal-Grill Experimental ModelPain
COMPLETED12 Analytics
PHASE1COMPLETED
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-39439335 in Patients With Osteoarthritis
Osteoarthritis, KneeUnlock trial analytics
PHASE1COMPLETED
An Exploratory Study to Assess the Effects of JNJ-39439335 on the Relief of Pain Using a Thermal-Grill Experimental Model
PainUnlock trial analytics

Study Endpoints

Primary Endpoints

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
The effects of JNJ-39439335 on the relief of paradoxical pain (the illusion of pain)
at predose and at 4 hours postdose

Secondary Endpoints

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
The effects of JNJ-39439335 on the non-painful cold and warm sensations corresponding respectively to the cold and warm temperatures used to induce paradoxical pain
at predose and at 4 hours postdose in each of the 2 treatment periods
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
001EXPERIMENTALJNJ-39439335 2 x 5 mg tablets once daily for 21 days
002EXPERIMENTALJNJ-39439335 2 x 25 mg tablets once daily for 21 days
003OTHERNaproxen 500 mg capsule every 12 hours for 21 days
004PLACEBO_COMPARATORPlacebo Placebo tablet/capsule every 12 hours for 21 days

Interventions

NameTypeDescription
PlaceboDRUGPlacebo tablet/capsule every 12 hours for 21 days
JNJ-39439335DRUG2 x 25 mg tablets once daily for 21 days
NaproxenDRUG500 mg capsule every 12 hours for 21 days
JNJ-39439335, PlaceboDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

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, crepitu...

Countries:South Africa
Unlock Eligibility Criteria

Competitive Landscape -Osteoarthritis 143 trials (matched to "Osteoarthritis, Knee")

Frequently asked questions about JNJ-39439335

What is JNJ-39439335 used for?

JNJ-39439335 is an investigational small molecule being studied for the treatment of knee osteoarthritis pain. It has been evaluated in Phase 1 clinical trials in patients with osteoarthritis of the knee, as well as in an exploratory pain study using a thermal-grill experimental model. It is not approved for any indication.

Who is developing JNJ-39439335?

JNJ-39439335 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 1 clinical program evaluating the compound in knee osteoarthritis pain and in an experimental pain model.

What phase is JNJ-39439335 in?

JNJ-39439335 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA or any other regulatory authority. Two Phase 1 trials have been completed, and no active trials are currently listed.

What clinical trials is JNJ-39439335 in?

JNJ-39439335 has been studied in two completed Phase 1 trials. NCT01343303 was a multiple-dose study evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics in 43 patients with knee osteoarthritis in South Africa. NCT01006304 was an exploratory study assessing pain relief using a thermal-grill experimental model in 12 healthy male volunteers.