Table 5.
Pain-free and headache relief with first dose, pain-free and headache relief with second dose as rescue medication, pain-free and headache relief with second dose to treat a recurrence/relapse (at 2 h postdose) and total pain-free rate with Indoprocaf-coated tablets and -effervescent tablets (intention-to-treat sample)*
| First attack | Second attack | Total attacks | ||||
|---|---|---|---|---|---|---|
| Indoprocaf tbs | Indoprocaf effe | Indoprocaf tbs | Indoprocaf effe | Indoprocaf tbs | Indoprocaf effe | |
| Pain-free (first dose) | 16/72 (22) | 29/71 (41)† | 23/70 (33) | 25/63 (40) | 39/142 (28) | 54/134 (40) |
| Headache relief (first dose) | 35/72 (49) | 47/71 (66)† | 45/70 (64) | 43/63 (68) | 80/142 (56) | 90/134 (67) |
| Pain-free (second doseas rescue medication) | 11/27 (41) | 10/19 (53) | 6/16 (38) | 6/9 (67) | 17/43 (40) | 16/28 (57) |
| Headache relief (second doseas rescue medication) | 14/27 (52) | 14/19 (74) | 10/16 (63) | 8/9 (89) | 24/43 (56) | 22/28 (79) |
| Pain-free (second doseto treat a recurrence/relapse) | 4/8 (50) | 9/18 (50) | 8/9 (89) | 6/10 (60) | 12/17 (71) | 15/28 (54) |
| Headache relief (second doseto treat a recurrence/relapse) | 7/8 (88) | 12/18 (67) | 9/9 (100) | 7/10 (70) | 16/17 (94) | 19/28 (68) |
| Total pain-free rate‡ | 52/72 (72) | 60/71 (85) | 52/70 (74) | 53/63 (84) | 104/142 (73) | 113/134 (84)† |
*
Values are number of attacks complying with the parameter/total no. of attacks (percentage). Indoprocaf indicates indomethacin, prochlorperazine and caffeine; tbs indicates coated tablets; effe indicates effervescent tablets.
†
p < 0.05 vs. Indoprocaf tbs.
‡
Total pain-free rate is the total percentage of attacks pain-free at 5 h without use of rescue medication and 2 h after the second dose of study drug as rescue medication.