Medical Services

Clinical Trials at Englewood Hospital: Osteoarthritis of the Knee

EHMC IRB
Study #:

E-12-466

 

 

 

 

 

 

 

 

 

 

   

Principal Investigator: 

Dr. Jeffrey Gudin

 

Tel: 201-568-5250

Email: pain2dr@yahoo.com

 

 

 

 

 

   

Study Coordinator: 

Mustafa Caylan

 

Tel: 201-894-3603

Email:  msalihcaylan@gmail.com

 

 

 

 

   

Sponsor:

Nektar Therapeutics

 

 

 

 

 

 

 

 

 

   

Study Title:

A Phase 2, Enriched-Enrollment, Randomized-Withdrawal, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Tolerability,

 

and Safety of NKTR-181 in Opioid-Naïve Subjects with Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee

 

   

Eligibility requirements:

Patients who are at least 18 years old with a diagnosis of osteoarthritis of the knee for at least six months.  Patients must be on a stable dose

 

 

of non-opioid pain medication (Ex. COX-2 selective inhibitor, NSAID, or acetaminophen.

 

 

 

 

   

Study objectives:

To determine the effectiveness of NKTR-181 by comparing change in pain scores from baseline to the end of randomization period.

   

Summary of procedures:

Eligible patients will record daily pain scores into an electronic diary.  Patients will continue to take their normal non-opioid pain medication

 

 

and begin taking NKTR-181 in increasing increments until a stable and effective dose is reached, which may take up to 30 days.  Patients who successfully 

 

complete this initial phase will then be randomized 1:1 to receive the NKTR-181 vs. placebo.  This randomized treatment phase will last up to 24 days.  

 

Throughout the study, patients continue the regular, non-opioid medication that they were on pre-study.  After the end of the randomized treatment

 

period, the patient will receive two follow-up phone calls - one at 7 days post treatment and one at 30 days post treatment.