| Disease | MULTICENTRE, RANDOMIZED, DOUBLE-BLIND PHASE III STUDY COMPARING DOSAGES OF 120 MG TWICE DAILY AND 12 MG TWICE DAILY OVER 8 WEEKS. RECOVERY (IN DB) OF THE AUDITORY THRESHOLD FROM THE INITIAL MEASUREMENT TO THE VALUE ON THE LAST DAY OF TREATMENT,
AVERAGED OVER THOSE FREQUENCIES FROM 0.25, 0.5, 1, 2, AND 3 KHZ FOR WHICH THE INITITAL HEARING LOSS AMOUNTED TO 15 DB OR MORE COMPARED TO THE LEVEL ON THE OPPOSITE SIDE. PATIENTS: 106 PATIENTS WITH AN AVERAGE AGE OF 44 + 16 YEARS AND WITH
HEARING LOSS AT AFFECTED FREQUENCIES 26 DB+9 DB INCLUDED BETWEEN DECEMBER 1995 AND JULY 1997. LARGE MAJORITIES OF BOTH TREATMENT GROUPS RECOVERED COMPETELY. IN EXPLORATORY ANALYSES OF THE 96 PATIENTS ACCORDING TO THE PROTOCOL, PATIENTS GIVEN
THE HIGHER DOSE HAD LESS RISK OF NOT RECOVERING WELL (<10 DB RESIDUAL HEARING LOSS) (ONE-SIDED FISCHER TEST: P=0.0061), ESPECIALLY IF THEY HAD NO TINNITUS.
A COMMERCIAL PRODUCT, EGB-761, WAS USED. |