Table 1.

Treated population for phase III and IIIb clinical trials with fentanyl iontophoretic transdermal system by age group

Study, year	Surgical procedures	Test product(s), dosage regimen, route of administration	All patients (N)	<65 years (n)	65–74 years (n)	75–84 years (n)	≥85 years (n)
Randomized, double-blind, placebo-controlled trials
C-95-016 [12]	Abdominal Orthopedic	A. Fentanyl ITS 40 µg up to 6 doses/h	77	71	5	1	0
		B. Placebo ITS	25	23	2	0	0
Chelly et al. [13], 2004	Abdominal Orthopedic Thoracic	A. Fentanyl ITS 40 µg up to 6 doses/h	154	120	20	13	1
		B. Placebo ITS	51	40	7	4	0
Viscusi et al. [14], 2006	Abdominal Orthopedic Thoracic Other	A. Fentanyl ITS 40 µg up to 6 doses/h	244	172	50	19	3
		B. Placebo ITS	240	187	35	16	2
Randomized, open-label, active-comparator trials
Viscusi et al. [15], 2004	Abdominal Orthopedic Thoracic Other	A. Fentanyl ITS 40 µg up to 6 doses/h	316	242	51	21	2
		B. Morphine IV PCA (1 mg/dose) up to 10 doses/h	320	258	41	20	1
Hartrick et al. [16], 2006	Orthopedic	A. Fentanyl ITS 40 µg up to 6 doses/h	395	213	113	65	4
		B. Morphine IV PCA (1 mg/dose) up to 10 doses/h	404	214	107	76	7
Minkowitz et al. [17], 2007	Abdominal Pelvic	A. Fentanyl ITS 40 µg up to 6 doses/h	252	206	26	18	2
		B. Morphine IV PCA (1 mg/dose) up to 10 doses/h	254	208	26	17	3
Grond et al. [18], 2007	Abdominal Orthopedic	A. Fentanyl ITS 40 µg up to 6 doses/h	325	240	60	21	4
		B. Morphine IV PCA maximum dosage of 20 mg/2 h	335	251	60	22	2
Total number of patients per age group			3392	2445	603	313	31

ITS iontophoretic transdermal system, IV PCA intravenous patient-controlled analgesia