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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
The main objective is the comparison of three different dosage regimens of hyaluronic acid in the treatment of osteoarthritis of the knee.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Hyaluronic acid 5 x 2.5 ml
Intervention: Hyaluronic acid 5 x 2.5 ml (Drug)
Hyaluronic acid 1 X 5 ml
Intervention: Hyaluronic acid 1 x 5 ml (Drug)
Hyaluronic acid 2 x 5 ml
Intervention: Hyaluronic acid 2 x 5 ml (Drug)
Outcomes
Primary Outcomes
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
- To evaluate the safety of the different dosage regimens(1 year)