This multicenter study was performed to evaluate the therapeutic efficacy and tolerability of galactosaminoglucuronoglycan sulfate (GAGGS) versus placebo. Included were 226 patients (192 evaluable cases) of both sexes, aged 41 and 67 years, with femorotibial gonarthritis, who were treated over a one-year period. During the 12-month study period, the signs and symptoms of the disease were evaluated, as well as cartilage thickness, with echographic examination: for all patients objective examinations were performed at baseline, after 14, 30, 90, 120, 180, 210, 240, and 330 days of treatment and again 30 days after administration of the last dose (T360). Echographic examinations were performed at baseline, and after 180 and after 360 days of treatment. To reduce the typical biases associated with evaluations performed by different persons in the various investigational centers, the study was carried out in triple-blind conditions versus placebo, with a single expert (blind to the treatment assigned to the patients) in charge of examining all the echographic findings recorded in the different study centers and with a single center in charge of statistical evaluation of the clinical data that received information on the content of treatment of the two groups after completion of statistical analysis. The echographic findings revealed that patients treated with GAGGS improved or preserved articular cartilage thickness while those receiving placebo showed a substantial decrease in articular cartilage thickness. A relationship between the trend in the signs and symptoms of gonarthritis in the two groups and the relative echographic data was observed. As to tolerability, side effects were recorded in two cases (2.6%) in the placebo-treated group and in six cases (6.9%) in the GAGGS group. The side effects were mild to moderate and did not require discontinuation of therapy in either treatment group. © 1992 Excerpta Medica, Inc., an Elsevier U.S. Holdings, Inc. Company. All rights reserved.
A MULTICENTER, TRIPLE-BLIND STUDY TO EVALUATE GALACTOSAMINOGLUCURONOGLYCAN SULFATE VERSUS PLACEBO IN PATIENTS WITH FEMOROTIBIAL GONARTHRITIS
TROTTA, Francesco;
1992
Abstract
This multicenter study was performed to evaluate the therapeutic efficacy and tolerability of galactosaminoglucuronoglycan sulfate (GAGGS) versus placebo. Included were 226 patients (192 evaluable cases) of both sexes, aged 41 and 67 years, with femorotibial gonarthritis, who were treated over a one-year period. During the 12-month study period, the signs and symptoms of the disease were evaluated, as well as cartilage thickness, with echographic examination: for all patients objective examinations were performed at baseline, after 14, 30, 90, 120, 180, 210, 240, and 330 days of treatment and again 30 days after administration of the last dose (T360). Echographic examinations were performed at baseline, and after 180 and after 360 days of treatment. To reduce the typical biases associated with evaluations performed by different persons in the various investigational centers, the study was carried out in triple-blind conditions versus placebo, with a single expert (blind to the treatment assigned to the patients) in charge of examining all the echographic findings recorded in the different study centers and with a single center in charge of statistical evaluation of the clinical data that received information on the content of treatment of the two groups after completion of statistical analysis. The echographic findings revealed that patients treated with GAGGS improved or preserved articular cartilage thickness while those receiving placebo showed a substantial decrease in articular cartilage thickness. A relationship between the trend in the signs and symptoms of gonarthritis in the two groups and the relative echographic data was observed. As to tolerability, side effects were recorded in two cases (2.6%) in the placebo-treated group and in six cases (6.9%) in the GAGGS group. The side effects were mild to moderate and did not require discontinuation of therapy in either treatment group. © 1992 Excerpta Medica, Inc., an Elsevier U.S. Holdings, Inc. Company. All rights reserved.I documenti in SFERA sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
