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

NCT02003118 | Completed Phase 2

• 1 other identifier: AKT-001
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• WOMAC

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

  8 weeks

Study Arms (2)

AKR 202

EXPERIMENTAL

Drug: AKR 202

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AKR 202 DRUG

AKR 202

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akron Molecules AG: lead

Study Sites (1)

Clinical study center

Vienna, Austria

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Study Director, MD

  Akron Molecules

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 6, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 23, 2014

Record last verified: 2014-10

Locations

AU (1)