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Hospital Based Trials

Six hospital-based clinical studies were performed, four in Australia and two in other countries. Five of these studies were randomised, double blind, placebo controlled design and the other study was open.  In all six studies patients were aged from 28 days to three(3) years.  The control product was either low potency colostrum or milk.  Combined analysis of these studies demonstrated a statistically significant reduction in the incidence of rotavirus infection in children given Gastrogard-R® compared with children not given Gastrogard-R® (p<0.001)

 

Study No.

No. evaluable patients

Incidence of symptomatic rotavirus diarrhoea

P

01-88

55 Gastrogard-R®
65 Control

0/55 Gastrogard-R®
9/65 Control

<0.001 

 02-90

23 Gastrogard-R®
47 Control

0/23 Gastrogard-R®
4/47 Control

N/S

03-90

27 Gastrogard-R®
52 Control

0/27 Gastrogard-R®
8/52 Control

0.029

01-91

No rotavirus infection in study  

 

 01-93

137 Gastrogard-R®
138 Control

11/137 Gastrogard-R®
7/138 Control

N/S

 01-95

253 Gastrogard-R®
108 Control

9/253 Gastrogard-R®
9/108 Control

0.04


 

 Revised Nov 2003

 

 

 





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