Efficacy and Safety of 3 Different Dosage Regimens of Hyaluronic Acid in Patients With Knee Osteoarthritis (OA)
NCT ID: NCT01290497
Last Updated: 2014-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
45 participants
INTERVENTIONAL
2010-11-30
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hyaluronic acid 5 x 2.5 ml
Hyaluronic acid 5 x 2.5 ml
5 intraarticular administration of Adant® 2.5ml with one week interval between administrations (standard treatment)
Hyaluronic acid 1 X 5 ml
Hyaluronic acid 1 x 5 ml
1 intraarticular administration of Adant® 5ml
Hyaluronic acid 2 x 5 ml
Hyaluronic acid 2 x 5 ml
2 intraarticular administration of Adant® 5ml with a two-week interval between administrations.
Interventions
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Hyaluronic acid 5 x 2.5 ml
5 intraarticular administration of Adant® 2.5ml with one week interval between administrations (standard treatment)
Hyaluronic acid 1 x 5 ml
1 intraarticular administration of Adant® 5ml
Hyaluronic acid 2 x 5 ml
2 intraarticular administration of Adant® 5ml with a two-week interval between administrations.
Eligibility Criteria
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Inclusion 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
* 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
45 Years
ALL
No
Sponsors
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Tedec-Meiji Farma, S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Alejandro Escudero
Role: PRINCIPAL_INVESTIGATOR
Locations
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Hospital Reina Sofia
Córdoba, Andalusia, Spain
Countries
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Other Identifiers
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2010-021633-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TM-ME3710/403
Identifier Type: -
Identifier Source: org_study_id
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