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

NCT ID: NCT02003118

Last Updated: 2014-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-07-31

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

AKR 202

Group Type: EXPERIMENTAL

AKR 202

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

AKR 202

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akron Molecules AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director, MD

Role: STUDY_DIRECTOR

Akron Molecules

Locations

Clinical study center

Vienna, , Austria

Countries

Austria

Other Identifiers

AKT-001

Identifier Type: -

Identifier Source: org_study_id