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

February 28, 2014 updated by: Tedec-Meiji Farma, S.A.

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: 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.
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tedec-Meiji Farma, S.A.

Investigators

  • Principal Investigator: Alejandro Escudero

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • TM-ME3710/403
  • 2010-021633-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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