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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Tedec-Meiji Farma, S.A..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Tedec-Meiji Farma, S.A.
ClinicalTrials.gov Identifier:
NCT01290497
First received: February 2, 2011
Last updated: May 9, 2011
Last verified: February 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Osteoarthritis of the Knee
 Drug: Hyaluronic acid 5 x 2.5 ml
Drug: Hyaluronic acid 1 x 5 ml
Drug: Hyaluronic acid 2 x 5 ml
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • To evaluate the safety of the different dosage regimens [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Safety endpoints: Recording of adverse events and physical examination


Enrollment: 45
Study Start Date: November 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01290497

Locations
Spain
Hospital Reina Sofia
Córdoba, Andalucia, Spain, 14004
Sponsors and Collaborators
Tedec-Meiji Farma, S.A.
Investigators
Principal Investigator: Alejandro Escudero
  More Information

No publications provided

Responsible Party: Mercedes Gimeno / R&D Director, Tedec-Meiji Farma
ClinicalTrials.gov Identifier: NCT01290497     History of Changes
Other Study ID Numbers: TM-ME3710/403, 2010-021633-31
Study First Received: February 2, 2011
Last Updated: May 9, 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 May 19, 2013