ABOUT THE STUDY

 

This clinical research study is testing the safety and effectiveness of a new investigational treatment for patients with severe knee pain due to osteoarthritis.

AM I ELIGIBLE?

 

You may be eligible to participate if you are 40-85 years old and have been diagnosed with moderate to severe osteoarthritis of the knee.

FAQs

 

Frequently asked questions. Learn more about the clinical research process and this study.

See if you or a loved one qualify!

AM I ELIGIBLE?

See if You or Your Loved One Qualify! You Must:

 

  • Be between 40-85 years old
  • Have been diagnosed with severe osteoarthritis of the knee
  • Have been experiencing chronic knee pain due to osteoarthritis of the knee for at least 6 months
  • Be ambulatory
  • Be willing and able to discontinue NSAID use for 48 hours prior to scheduled clinical efficacy evaluations
  • Have no history of inflammatory or crystal arthropathies, acute fractures, aseptic necrosis or joint replacement in the affected knee.
  • Have no history of isolated patella femoral syndrome, also known as chondromalacia
  • Not have another disease or condition interfering with the target knee
  • Not have any other pain that might interfere with the assessment of index knee pain

 

There are other qualifications for this study that a representative will discuss with you.

ABOUT THE AP-013 OA TRIAL

This study is testing the safety and effectiveness of a new investigational treatment for patients with severe knee pain due to osteoarthritis.

Before beginning the AP-013 OA Trial, you will be screened for eligibility. If you are determined to be eligible and you agree to participate, you will be randomly placed into one of the dosing groups, with groups receiving either an active or placebo version of the injection. 50% of participants will receive the study drug, and 50% will receive the placebo.

 

Your participation in the study will span 24 weeks, including 4 visits to the study clinic and 7 phone conversations with study staff. Over the course of the study, you will receive either the active or placebo version of the investigational drug and have doctors monitor your health and progress through study-related tests and assessments.

Qualified participants may be compensated for time and travel.

WHAT IS OSTEOARTHRITIS?

 

Osteoarthritis (OA) is the most common form of arthritis, and the major cause of activity limitation and physical disability. Today, 35 million people (13% of the US population) are 65 and older, and more than half of them have radiological evidence of OA in at least 1 joint.

 

Common symptoms include pain, stiffness, a grinding sensation when moving the joints, swelling.

FREQUENTLY ASKED QUESTIONS

What is a clinical research study?

A clinical research study tests the safety and effectiveness of a new investigational medication in a population of volunteer patients. Every investigational medication, treatment, or medical device goes through the clinical trial process. Therefore, participants play a very important role in advancing medicine for present and future generations.

What is an investigational medication?

An investigational medication has not been approved by the U.S. Food and Drug Administration (FDA) but is allowed to be administered to people for research purposes.

What is a Placebo?

A placebo is often similar in appearance to the investigational medication but does not contain any active ingredients.

What are my rights as a participant and what will happen if I decide not to participate?

Your participation in this study is voluntary. You can decide to stop at any time and you may still be treated at the facility. Your decision whether or not to take part in the study will not affect your current or future care at the facility.

 

Tell your study doctor if you are thinking about stopping or decide to stop. You should talk to the study doctor about leaving the study before you decide so that he/she can find out if you are having any side effects from study treatment, and he/she can tell you how to stop safely.

How can I learn more about the investigational medication and this study?

More information on this clinical trial can be found on clinicaltrials.gov.

This study is being conducted by Ampio Pharmaceuticals, Inc.