Overview

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

Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
0
Participant gender:
All
Summary
This proof of concept study will be a placebo controlled, randomised, double blind, parallel study. The purpose of the study is to determine efficacy for AKR 202 in the treatment of osteoarthritis (OA) pain in the knee.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Akron Molecules AG
Criteria
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.