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Clinical Trials/NCT01290497
NCT01290497CompletedPhase 4

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

Tedec-Meiji Farma, S.A.1 site in 1 country45 target enrollmentStarted: November 2010Last updated:
Conditions
Interventions

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

Active Comparator

Intervention: Hyaluronic acid 5 x 2.5 ml (Drug)

Hyaluronic acid 1 X 5 ml

Experimental

Intervention: Hyaluronic acid 1 x 5 ml (Drug)

Hyaluronic acid 2 x 5 ml

Experimental

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)

Investigators

Sponsor
Tedec-Meiji Farma, S.A.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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