Efficacy and Safety of 3 Different Dosage Regimens of Hyaluronic Acid in Patients With Knee Osteoarthritis (OA)

Study Overview
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Brief Summary
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The main objective is the comparison of three different dosage regimens of hyaluronic acid in the treatment of osteoarthritis of the knee.

Official Title
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Pilot, Unicentre, Randomized, Parallel, Controlled Study to Evaluate the Efficacy and Safety of Three Different Intraarticular Dosage Regimens of Adant® in Patients With Osteoarthritis of the Knee

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: Hyaluronic acid 5 x 2.5 ml
* Drug: Hyaluronic acid 1 x 5 ml
* Drug: Hyaluronic acid 2 x 5 ml


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatient>45 years of age diagnosed with primary osteoarthritis according to ACR and Kellgren criteria Knee pain ≥ 55 mm and ≤90 mm measured by Visual Analogue Scale (VAS) 100 mm Ability to understand and follow study procedures Written informed consent Exclusion Criteria: Patients with secondary osteoarthritis of the knee according to ACR criteria. Severe inflammation of the knee diagnosed by physical examination or a sedimentation speed rate < 40 mm/h and serum rheumatoid factor titre < 1:40 Patients having previously received surgery, including arthroscopy Patients with joint inflammatory disease (spondilitis, systemic rheumatoid arthritis), microcrystalline arthropathies (chondrocalcinosis, gout, fibromyalgia) and significant osteoarthritis symptoms in other joints apart from the knee, and which require pharmacological treatment Previous administration of any of the following treatments: hyaluronic acid ia (last year); steroids i.a. or joint lavage (last 3 months), glucosamine sulfate, chondroitin sulfate or diacerein (last 3 months), NSAIDs (last 14 days), any investigational drug (last month) or its administration during this study

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hyaluronic acid 5 x 2.5 ml<br> | Drug: Hyaluronic acid 5 x 2.5 ml<br>* 5 intraarticular administration of Adant® 2.5ml with one week interval between administrations (standard treatment)<br>|
| Experimental: Hyaluronic acid 1 X 5 ml<br> | Drug: Hyaluronic acid 1 x 5 ml<br>* 1 intraarticular administration of Adant® 5ml<br>|
| Experimental: Hyaluronic acid 2 x 5 ml<br> | Drug: Hyaluronic acid 2 x 5 ml<br>* 2 intraarticular administration of Adant® 5ml with a two-week interval between administrations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main objective is to evaluate the efficacy of different dosage regimens of intraarticular Hyaluronic Acid 5 ml (Adant®)compared to a standard treatment (2.5ml X 5 i.a) in patients with osteoarthritis of the knee. | Primary endpoint: Pain, Function and patient's assessment according to OARSI 2004 responder criteria. Every patient who has received 100% of injections by the end of the study and has fulfilled the follow-up visits will be considered evaluable. The percentage of patients in each group who do not complete the study due to lack of efficacy will be evaluated. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of the different dosage regimens | Safety endpoints: Recording of adverse events and physical examination | 1 year |