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

Phase 4

Completed

• Conditions: Osteoarthritis of the Knee
• Interventions: Drug: Hyaluronic acid 1 x 5 ml; Drug: Hyaluronic acid 5 x 2.5 ml; Drug: Hyaluronic acid 2 x 5 ml

• Registration Number: NCT01290497
• Lead Sponsor: Tedec-Meiji Farma, S.A.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-02-02
• Study First Submitted QC: 2011-02-04
• Study First Posted: 2011-02-07
• Primary Completion: 2011-10
• Study Completion: 2011-11
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-28
• Last Update Posted: 2014-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronic acid 1 X 5 ml	Hyaluronic acid 1 x 5 ml	-
Hyaluronic acid 5 x 2.5 ml	Hyaluronic acid 5 x 2.5 ml	-
Hyaluronic acid 2 x 5 ml	Hyaluronic acid 2 x 5 ml	-

Primary Outcome Measures

Name	Time	Method
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.	1 year	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.

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety of the different dosage regimens	1 year	Safety endpoints: Recording of adverse events and physical examination

Trial Locations

Locations (1)

Hospital Reina Sofia; 🇪🇸 Córdoba, Andalucia, Spain