Table 2.

Primary, Secondary and Additional End Points

	Placebo		Clonidine
	Before	During	Before	During
Bowel habits
Stool frequency/day	2.7 ± 0.2	2.4 ± 0.2	2.4 ± 0.2	2.1 ± 0.1
Stool consistency (Bristol stool form score)	4.0 ± 0.2	3.8 ± 0.2	3.7 ± 0.2	3.4 ± 0.2
Bristol form 5–7 (% of all bowel movements)	41 ± 5 %	36 ± 6	31 ± 5	21 ± 4
Duration for which defecation could be deferred (minutes)	4.4 ± 1.3	5.2 ± 1.5	3.6 ± 0.7	5.6 ± 1.9
Proportion of complete bowel movements (%)	51 ± 6	60 ± 6	71 ± 7	72 ± 7
Rectal urgency
Bowel movements preceded by urgency (%) b	59 ± 5	46 ± 6	55 ± 4	46 ± 6
Incontinent bowel movements preceded by urgency (%)	74 ± 6	69 ± 7	75 ± 7	71 ± 8
Fecal incontinence
Number of days with FI b	16 ± 2	11 ± 2	13 ± 1	8 ± 1
Number of FI episodes b	31 ± 5	19 ± 4	20 ± 3	12 ± 3
Proportion of bowel movements which were incontinent (%)	40 ± 6	27 ± 6	31 ± 4	24 ± 5
Volume of FI (% of all bowel movements)
Staining only (%)	19 ± 4	17 ± 5	11 ± 3	9 ± 2
Moderate FI (%)	13 ± 3	7 ± 2	12 ± 3	7 ± 3
Full bowel movement (%)	8 ± 2	4 ± 1	8 ± 2	7 ± 2
Composition of leakage
Bristol form 5–7 (% stools)	57 ± 7	57 ± 8	54 ± 7	46 ± 9
Mean weekly FICA symptom severity score a # (maximum = 13)	9.1 ± 0.3	7.6 ± 0.5	8.1 ± 0.4	6.5 ± 0.6
Fecal incontinence severity index (Rockwood score) b †	37.3 ± 2.5	31.2 ± 2.5	36.2 ± 2.7	29.3 ± 2.8
Fecal incontinence quality of life (Rockwood score) b †
Lifestyle score	2.3 ±0.2	2.7 ± 0.2	2.8 ± 0.2	3.1 ± 0.2
Coping score	1.6 ± 0.1	2.1 ± 0.1	1.8 ± 0.1	2.3 ± 0.2
Depression score	2.9 ± 0.2	3.2 ± 0.2	3.2 ± 0.2	3.5 ± 0.1
Embarrassment score	2.3 ± 0.2	2.5 ± 0.2	2.2 ± 0.2	2.8 ± 0.2
Satisfaction with therapy (100 mm VAS) b #	18 ± 4	38 ± 6	22 ± 6	47 ± 6
Loperamide use (% days) b	4 ± 2	5 ± 2	3 ± 1	2 ± 0

All parameters were computed from daily diaries except for those marked with # (weekly diaries) and † (pre and post treatment questionnaire)

^aPrimary endpoint

^bSecondary endpoint