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

Phase 2

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: AKR 202; Drug: Placebo

• Registration Number: NCT02003118
• Lead Sponsor: Akron Molecules AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-06
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-21
• Last Update Posted: 2014-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AKR 202	AKR 202	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
WOMAC	8 weeks	Change from baseline in WOMAC pain subscale at Week 8 or at the final visit at the time of patient discontinuation

Trial Locations

Locations (1)

Clinical study center; 🇦🇹 Vienna, Austria