Skip to main content
OpenTrials
Completed

NCT Number: NCT00669032

Efficacy and Safety of Repeated Intraarticular Injections of Hyaluronic Acid in Patients With OA of the Knee

The main objective is the long-term comparison (3 years and 4 months) of the efficacy and safety of repeated intra-articular administration of hyaluronic acid in the treatment of osteoarthritis of the knee.

Completed

Looking for future studies?

Notify Me

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

Not applicable

About this study

To evaluate the efficacy and safety of repeated injections of hyaluronic acid compared with placebo over a period of 40 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient > 45 years of age
  • Out-patient diagnosed with primary osteoarthritis of the femorotibial medial joint of the knee with clinical and radiological (Kellgren grade II-III) ACR diagnosis
  • Joint Space Width (JSW) > 2mm
  • Overall pain greater or equal to 55mm (VAS - Visual Analogue Scale 100mm) recorded in the knee,by the patient at any time during the week prior to the evaluation

Exclusion criteria

  • Overweight patients (body mass index > 32).
  • Pregnant and lactating women. Women of child-bearinge age not using effective contraception
  • Patients who have received intra-articular hyaluronic acid within the previous year and/or intra-articular steroids or articular lavage in the chosen knee,within the previous 3 months prior to their inclusion in the study.
  • AINE administration within the 14 days prior to their inclusion in the study.
  • Administration of glucosamine sulphate, chondroitin sulphate and diacerein within the 3 months prior to their inclusion in the study.
  • Immunocompromised patients or patients receiving systemic immunosuppressive therapy.
  • Patients with known sensitivity to HA, parcetamol or AINEs permitted as rescue medication.
  • Patients who have received any investigational drug within 30 days prior to visit 1, or who are scheduled for the administration of an investigational drug other than the protocol product during this study.
  • Patients with severely impaired central nervous system.
  • Patients with coagulation alterations, despite receiving treatment.
  • Patients with secondary osteoarthritis of the knee
  • Patients having previously received surgery, including arthroscopy
  • Patients with articular inflammatory disease

Treatment and study plan

Hyaluronic Acid

Device

3 cycles of 5 hyaluronic acid injections, with a 6 month interval between each one. A 4th treatment cycle of five injections will be carried out at the end of one year

Placebo

Other

3 cycles of 5 saline solution injections, with a 6 month interval between each one. A 4th treatment cycle of five injections will be carried out at the end of one year

Primary outcomes

  1. Responders OARSI 2004 at the End of Follow-up

    Time frame: 40 months

    Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at the end of follow-up. Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.

    The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome.

Secondary outcomes

  1. Responders OARSI 2004 at 7 Months Follow-up Visit

    Time frame: 7 months (6 months after first cycle)

    Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 7 months follow-up visit (6 months after first cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.

    The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome.

  2. Responders OARSI 2004 at 14 Months Follow-up Visit

    Time frame: 14 months (6 months after second cycle)

    Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 14 months follow-up visit (6 months after second cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.

    The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome.

  3. Responders OARSI 2004 at 21 Months Follow-up Visit

    Time frame: 21 months (6 months after third cycle)

    Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 21 months follow-up visit (6 months after third cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.

    The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome.

  4. Responders OARSI 2004 at 27 Months Follow-up Visit

    Time frame: 27 months (12 months after third cycle)

    Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 27 months follow-up visit (12 months after third cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.

    The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome.

  5. Responders OARSI 2004 at 34 Months Follow-up Visit

    Time frame: 34 months (6 months after fourth cycle)

    Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 34 months follow-up visit (6 months after fourth cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.

    The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome.

  6. Pain or Function Scores Reduction 50% (20mm) at the End of Follow-up

    Time frame: 40 months

    Percentage of patients with a decrease in pain or physical function score of at least 50% and at least 20mm on the VAS at the end of follow-up.

    The VAS is set between 0-100mm, higher values represent a worse outcome.

  7. Overall Pain Reduction 20% (10mm) at the End of Follow-up

    Time frame: 40 months

    Percentage of patients with a decrease in pain score of at least 20% or at least 10mm on the VAS at the end of follow-up.

    The VAS is set between 0-100mm, higher values represent a worse outcome.

  8. Function Improvement 20% (10mm) at the End of Follow-up

    Time frame: 40 months

    Percentage of patients with a decrease in physical function score of at least 20% or at least 10mm on the VAS at the end of follow-up.

    The VAS is set between 0-100mm, higher values represent a worse outcome.

  9. Patient's Global Assessment Increase 20% (10mm) at the End of Follow-up

    Time frame: 40 months

    Percentage of patients with an increase in the score of patient's global assessment by at least 20% and at least 10mm on the VAS at the end of follow-up.

    The VAS is set between 0-100mm, higher values represent a better outcome.

  10. Percentage of Patients Who Consumed Rescue Medication for Osteoarthritis

    Time frame: Throughout the study, an average of 40 months

    Consumption of rescue medication (paracetamol/NSAID) for osteoarthritis throughout the study, an average of 40 months

  11. Mean Daily Dose of Paracetamol Consumption

    Time frame: Throughout the study, an average of 40 months

    Mean daily dose of paracetamol consumption throughout the study, an average of 40 months

Sponsors and collaborators

Lead sponsor

Tedec-Meiji Farma, S.A.

Industry

Registry information

Official study title

Random, Phase IV, Multicentre, Double Blind, Placebo Controlled, Parallel Study to Assess Long-term Efficacy and Safety of Repeated Intraarticular Injections of Hyaluronic Acid (ADANT®) in Patients With Knee OA of the Knee

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Apr 29, 2008
Registry last updated
Aug 28, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.