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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tedec-Meiji Farma, S.A.
ClinicalTrials.gov Identifier:
NCT00669032
First received: April 25, 2008
Last updated: November 10, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Osteoarthritis of the Knee
Device: Hyaluronic acid
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Random, Phase IV, Multicentre, Double Blind (Patient and Evaluator 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.

Resource links provided by NLM:


Further study details as provided by Tedec-Meiji Farma, S.A.:

Primary Outcome Measures:
  • The main objective of this study is maximum overall pain in the knee during the week prior to the evaluation, measured by the Visual Analogue Scale 100mm. The basal score will be compared with the scoring obtained in each follow-up visit. [ Time Frame: 3 years and 4 months ] [ Designated as safety issue: No ]

Enrollment: 306
Study Start Date: October 2003
Study Completion Date: December 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: Hyaluronic acid
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 Comparator: 2 Other: Placebo
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

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669032

Sponsors and Collaborators
Tedec-Meiji Farma, S.A.
Investigators
Principal Investigator: Federico Navarro Sarabia
  More Information

No publications provided by Tedec-Meiji Farma, S.A.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tedec-Meiji Farma, S.A.
ClinicalTrials.gov Identifier: NCT00669032     History of Changes
Other Study ID Numbers: TM-ME3710/304, 2006-001854-28
Study First Received: April 25, 2008
Last Updated: November 10, 2011
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014