Bioiberica Farma leads a new clinical trial in osteoarthritis of the knee, on the efficacy and safety of the combination of chondroitin sulfate and Glucosamine.
American annual Congress of 2011 Rheumatology (ACR).
– is a multicenter clinical trial, with 560 patients from Spain, Germany, France and Poland of 6-month
-the goal of the MOVES (Multicenter Osteoarthritis InterVEntion trial with Sysadoas) is to continue providing evidence of the efficacy and safety of the combination of chondroitin sulfate and Glucosamine in the treatment of moderate to severe in patients with osteoarthritis of knee pain
Chicago, November 2011- Bioiberica Farma has submitted last Wednesday a new clinical trial to continue providing evidence of the efficacy and safety of the combination of chondroitin sulfate and Glucosamine in the treatment of moderate to severe in patients with osteoarthritis of knee pain.
The Studio MOVES (Multicenter Osteoarthrits InterVEntion trial with Sysadoas) is designed according to standards of good clinical practice, current legislation and regulations for the investigation of drugs in osteoarthritis. Consists of a clinical trial phase IV, multicenter, randomized, of non inferiority and parallel groups, double blind and controlled, six-month duration. includes 560 participants with arthrosis of knee primary and moderate to severe pain of Spain, Germany, France and Poland. Patients will receive 1200mg chondroitin sulfate and 1500 mg of Glucosamine per day hydrochloride, or 200 mg of an anti-inflammatory. The main evaluation criteria will be the reduction of the pain of the patient with respect to the start in the subscale WOMAC, after six months of treatment. Security settings will also be registered. Supervision of this clinical trial has been established a Scientific Committee consisting of national and international specialists of recognised prestige. In total, 37 centres participating in the study of which 14 are Spanish. The MOVES already is currently in phase of recruitment of patients.
The presentation of the clinical trial has been carried out by Professor Marc c Hochberg, head of the Division of Rheumatology and Immunology clinic of the University of Maryland (United States), at the annual Congress of the American College of Rheumatology (ACR), held these days in Chicago and in which participated 15,000 rheumatologists.
Professor Hochberg has pointed out that the treatment of patients with osteoarthritis of knee with moderate to severe pain includes the use of different modalities not pharmacological as well as agents pharmacological, which include anti-inflammatory non drugs (NSAIDs), analgesics, therapies intrarticulares and symptomatic slow acting for osteoarthritis (chondroitin) drugs(Glucosamine and diacerein).
His presentation focused on the data of efficacy and safety of the combination of chondroitin sulfate and Glucosamine and has particularly stressed the results of the study GAIT (Glucosamine/Chondroitin Arthritis Intervention Trial). This study found that patients with moderate to severe pain treated with such a combination had a statistically significant placebo effect in the main assessment parameter (20% reduction in pain on the WOMAC scale) as well as in the majority of secondary parameters evaluated. Precisely the results of this study were that led to the Organization of the clinical trial MOVES which was submitted last Wednesday.
The Medical Director and scientist of Bioiberica Farma, Dr. Josep Vergés, clinical pharmacologist, has stated the importance of this study as positive results will serve to continue providing evidence on the effectiveness of these drugs, as well as additional information to compare the safety and tolerability of treatments for arthrosis ”.
Bioiberica Farma is the only Spanish company present in the Educational Programme of the American College of Rheumatology, and in particular, is the sixth symposium organized in this Congress, this year under the title update on arthritis: Pathophysiology and treatment Farmacológico. Thus, Bioiberica Pharma has made it possible for years that the concept of the chondroprotection be presented and disseminated in the Congress with very good reception from the American Academy of Rheumatology, illustrating worldwide on the efficacy and safety of these treatments in the management of osteoarthritis.