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Última actualización:
11 de junio de 2013
BIOIBERICA NEWS

July 19, 2012
More than 450 knee osteoarthritis patients are participating in a clinical trial that intend to confirm the efficacy of the combination of chondroitin sulphate and glycosamine.
It is a phase IV clinical trial currently being carried out in 38 medical centers in Spain, Germany, France and Poland.
The objective of the MOVES (Multicenter Osteoarthritis InterVEntion trial with Sysadoas) it is to prove that combining chondroitin sulfate and glucosamine sulfate is as efficient as celecoxib for the treatment of moderate to severe pain in knee osteoarthritis.
The study was presented at the 6th European Congress of Pharmacology that it is being held in Granada.

Foreign and national experts discussed today the latest scientific evidence of the efficacy of SYSADOAs for osteoarthritis (OA) treatment at the 6th European Congress of Pharmacology held in Granada last week.

One of the most interesting features of the congress was the presentation of the MOVES trial (Multicenter Osteoarthritis InterVEntion trial with Sysadoas) by Dr. Jordi Monfort, rheumatologist at the Hospital del Mar in Barcelona. This new clinical trial, that it is coordinated by Bioibérica Farma, involved more than 500 patients who suffer primary knee OA with moderate to severe pain, coming from Spain, Germany, France and Poland. The study has been developed in collaboration with the Agencia Española del Medicamento (AEMPS), following good clinical practice guidelines, the existing legislation, and the normative for OA drug research. It is a multicenter, random, no-inferiority, parallel group, controlled and double blind phase IV clinical trial which lasted six months. Patients received daily doses of 1,200 mg of chondroitin sulfate and 1,500 mg of glucosamine hydrochloride, or 200 mg of celecoxib over a six month period.

The main evaluation criteria was pain improvement as per the WOMAC subscale, after a six-month treatment. They will also evaluate security parameters. A scientific committee was formed to overview that clinical essay. Its members include renowned foreign and international experts: among them, professor Patrick du Souick, president of the IUPHAR (International Union of Basic and Clinical Pharmacology), or professor Philip Conaghan, president of the group for the development of OA guidelines of the United Kingdom’ National Institute for Health and Clinical Excellence (NICE). 38 medical centers, 14 of them Spanish, are participating in this study.

Dr. Monfort’s lecture put the focus on the results of the GAIT (Glucosamine/Chondroitin Arthritis Intervention Trial) trial sponsored by the US National Health Institute. The research team noticed that patients with moderate to severe pain who receive Glucosamine and Chondroitin Arthritis performed significantly better in the main evaluation criteria than the group being given a placebo (20% reduction in pain in the WOMAC scale) as well as in most secondary criteria. These positive results led scientist to develop the clinical trial MOVES, which it is being presented today.

According to Dr. Monfort, “these positive results contribute complimentary evidence on the efficacy and synergic effects of both drugs, as well as further information that will allow us to compare security and tolerability of several different OA treatments”. In this regard, Dr. Antonio García, professor at the Pharmacology Department of the Universidad Autónoma de Madrid, pointed out that, over the last two decades, some twenty clinical trials and five meta analysis have demonstrated a positive efficacy/risk relationship between the SYSADOAs chondroitin sulfate and Glucosamine sulfate. According to Dr. García, “the data extracted from more than 3,000 cases lead us to the conclusion that chondroitin sulfate and glycosamine sulfate significantly improve pain and joint function when compared to placebo treatments. Furthermore, a number of recent studies suggest that these compounds might delay or even stop the development of OA”. 




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