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Completed

NCT Number: NCT01290497

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

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

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Reina Sofia

Córdoba, Andalusia, 14004, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyaluronic acid 5 x 2.5 ml

Drug

5 intraarticular administration of Adant® 2.5ml with one week interval between administrations (standard treatment)

Hyaluronic acid 1 x 5 ml

Drug

1 intraarticular administration of Adant® 5ml

Hyaluronic acid 2 x 5 ml

Drug

2 intraarticular administration of Adant® 5ml with a two-week interval between administrations.

Primary outcomes

  1. 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.

Secondary outcomes

  1. To evaluate the safety of the different dosage regimens

    Time frame: 1 year

    Safety endpoints: Recording of adverse events and physical examination

Sponsors and collaborators

Lead sponsor

Tedec-Meiji Farma, S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 7, 2011
Registry last updated
Mar 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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