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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.

19 Jul 2012
Healthcare

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
”.