A Placebo Controlled, Double Blind, Randomised, 8-week Phase IIa Proof of Concept Study to Assess the Efficacy and Safety of AKR 202 in Patients With Osteoarthritis Pain

Inclusion criteria

Patient is between 40 and 75 years of age with a clinical diagnosis of OA of the knee for more than 6 months prior to Visit 1 based on clinical and radiographic criteria, and being of American Rheumatism Association (ARA) functional Class I, II, or III. Patients should have an average pain level of between 4 and 8 on a Numeric Rating Scale (NRS) for at least 5 of 7 days before the randomisation, when answering the question: Please, rate the average pain in your index knee during the last 24 hours. Prior to the study, patients should have been using pharmacological treatments, such as Non-Steroidal Anti-Inflammatory Drug (NSAIDs), acetaminophen or weak opioids for their OA pain on a regular basis (defined as having used NSAIDs, acetaminophen or weak opioids at least 10 days out of 30 days during the last month prior to the screening visit).

Exclusion criteria

Patient has a concurrent medical/arthritic disease that could confound or interfere with evaluation of efficacy.

Patients with impaired renal function, defined as an estimated creatinine clearance less than or equal to 50 ml/min, or patients taking medications that might impair renal function.

Patient has New York Heart Association (NYHA) Class III-IV congestive heart failure.

The patient has a history of uncontrolled hypertension or a current blood pressure that in the opinion of the Investigator makes the patient unsuitable for the study.

Patients with a trauma or surgery at the index knee within 3 months prior to screening.