A study comparing the safety and efficacy of AKR 202 with placebo in patients with osteoarthritis pain.

Conditions: Moderate to severe osteoarthritis pain in the index knee
MedDRA version: 16.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2013-001701-85-CZ

Lead Sponsor: Akron Molecules GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 260

Inclusion Criteria

1. Willing and able to provide informed consent
2. Patient is between 40 and 75 years of age
3. Clinical diagnosis of OA of the knee for more than 6 months prior to Visit 1 based on clinical and radiographic criteria
4. Patient is of American Rheumatism Association (ARA) functional Class I, II, or III
5. 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
6. Patients should use pharmacological treatments, such as Non-Steroidal Anti-Inflammatory Drug (NSAIDs), acetaminophen or weak opiods for their OA pain on a regular basis (defined as having used NSAIDs, acetaminophen or weak opiods at least 10 days out of 30 days during the last month prior to the screening visit)
7. Female patients of childbearing potential must have a negative pregnancy test prior to study enrolment
8. Patient is using adequate contraceptive measures from Visit 1 until 3 months after the last dose of IMP
Female patients who have been post-menopausal for more than one year or female patients of childbearing potential using a highly efficient method of contraception (i.e. a method with less than 1% failure rate [e.g. sterilisation, hormone implants, hormone injections, some intrauterine devices, or vasectomised partner])
Male patients agreeing to use condoms during the study and for 3 months after the last dose of the IMP, or patients having a partner who is using a highly efficient method of contraception as described above
9. Patient is willing to avoid unaccustomed physical activity for the duration of the study and follow-up period
10. With the exception of OA, the patient is judged, by the Investigator, to be in good general health based on medical history, physical exam, and routine laboratory tests
11. Patient is able to read, hear, understand, and complete study questionnaires, including questions requiring a NRS

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1. Patient has a concurrent medical/arthritic disease that could confound or interfere with evaluation of efficacy
2. Patient is legally incompetent (e.g., a minor or mentally incapacitated), or has active psychosis, or significant emotional problems at the time of the study which in the view of the Investigator are sufficient to interfere with the conduct of the study
3. Patient has a history of gastric or biliary surgery (including gastric bypass surgery), or small intestine surgery, either of which causes clinical malabsorption
4. Patient has a history of Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV), or positive viral test result for Hepatitis B or C or HIV 1 or 2
5. Patient is allergic to, or has a history of a significant clinical or laboratory adverse experience associated with AKR 202 or any of its constituents
6. Patient has an estimated creatinine clearance less than or equal to 50 ml/min, or patients taking medications that might impaire renal function
7. Patient has New York Heart Association (NYHA) Class III-IV congestive heart failure
8. 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
9. Patient has moderate or severe hepatic insufficiency defined as Child Pugh score >6, or serum transaminase levels (Alanine Aminotransferase [ALT] or Aspartate Aminotransferase [AST]) of >1.5 X upper reference level for normal
10. Patient has a history of neoplastic disease within the last 5 years, or a current neoplastic disease, with the exception of basal carcinoma
11. Patient has a history of any illness, which in the opinion of the Investigator, might confound the results of the study or pose additional risk to the patient
12. Patient has a history of alcohol or substance abuse
Patient is, at the time of screening, a user of recreational or illicit drugs or has had a recent history (within the last 2 years) of drug or alcohol abuse or dependence. Or the patient has a currently weekly alcohol consumption of >14 units for females and >21 units for males
13. Patients considered morbidly obese with a Body Mass Index (BMI) =40 kg/m2
14. Patient has (within 4 weeks of the screening visit ,Visit 1) started or changed the following non medical treatment: physical medicine modalities involving the study joint, including but not limited to: physical therapy, chiropractic interventions, acupuncture, herbal medication administered for OA, Transcutaneous Electrical Nerve Stimulator (TENS), and ultrasound
15. Patients with a trauma or surgery at the index knee within 3 month prior to screening (Visit 1)
16. Patient is expected to undergo in-patient hospitalisation or any planned surgery during the course of the study
17. Patients using oral or injectable steroids or other immunosuppressant medication within 2 months prior to screening (Visit 1)
18. Patients using corticosteroid, hyaluronic acid or Autologous Conditioned Plasma (ACP) injections to any joint within 2 months prior to screening (Visit 1)
19. Patients using topical or systemic analgesic medications not allowed in the study protocol at any time during the study, with the exception of low-dose aspirin (=325 mg/day) used for prophylaxis of cardiovascular events
20. Patients with clinically significant abnormalities, as judged by the Investigator, on Visit 1 clinical examination or laboratory safety tests
21. Patients currently partici

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of AKR 202 for the treatment of patients with moderate to severe osteoarthritis (OA) pain in the index knee;Secondary Objective: To ssess the safety and tolerability of AKR 202 in patients with moderate to severe OA pain in the index knee.<br><br>To assess further aspects of efficacy of AKR 202 (such as Patient Global Assessment, Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] pain subscale, stiffness, physical function scores);Primary end point(s): Change from baseline in WOMAC pain subscale at Week 8 or at the final visit at the time of patient discontinuation;Timepoint(s) of evaluation of this end point: Primary endpoint: Week 8 or at the final visit at the time of patient discontinuation

Secondary Outcome Measures

Name	Time	Method

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