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

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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Drug: Hyaluronic acid 5 x 2.5 ml; Drug: Hyaluronic acid 1 x 5 ml; Drug: Hyaluronic acid 2 x 5 ml

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Andalucia
    • Córdoba, Andalucia, Spain, 14004
      • Hospital Reina Sofia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tedec-Meiji Farma, S.A.
• Investigators: Principal Investigator: Alejandro Escudero

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: February 2, 2011
• First Submitted That Met QC Criteria: February 4, 2011
• First Posted (Estimate): February 7, 2011

Study Record Updates

• Last Update Posted (Estimate): March 3, 2014
• Last Update Submitted That Met QC Criteria: February 28, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: TM-ME3710/403; 2010-021633-31 (EudraCT Number)