Otilonium bromide in irritable bowel syndrome: A dose-ranging randomized double-blind placebo-controlled trial

Table 1 Baseline demographic and clinical characteristics n (%)

Characteristic	Placebo	OB 20 mg	OB 40 mg	OB 80 mg	Total
	(n = 23)	(n = 24)	(n = 23)	(n = 23)	(n = 93)
Demographic
Age (yr)	47.8 ± 13.1	44 ± 12.71	44.6 ± 13.66	42.9 ± 11.12	44.8 ± 12.6
Female patients	16 (69.6)	16 (66.7)	16 (69.6)	16 (69.6)	64 (68.8)
Height (cm)	166.4 ± 7.9	170.4 ± 9.7	166.1 ± 7.8	170.2 ± 10.9	168 ± 9.24
Weight (kg)	69.8 ± 15.9	72.9 ± 16.6	68.9 ± 12.9	74.4 ± 16.9	71.5 ± 15.6
Baseline ano-rectal parameters
Anal canal length (mm)	33.7 ± 1.6	34.6 ± 8.9	33.4 ± 9.8	33.6 ± 8.1	33.8 ± 9.4
Depth of insertion probe (mm)	24.8 ± 18.8	24.9 ± 14.3	24.2 ± 16.7	28.8 ± 18.1	25.6 ± 16.7
Sphincter pressure (mmHg)	51.9 ± 19.2	50.7 ± 16.4	54.4 ± 21.2	49.4 ± 20.2	51.6 ± 19
Baseline symptom severity
Intensity of abdominal pain1	2.7 ± 0.9	2.04 ± 0.94	2.19 ± 0.98	2.19 ± 0.8	2.2 ± 0.91
Frequency of abdominal pain1	3.09 ± 1.83	3.55 ± 3.72	2.79 ± 2.14	3.35 ± 2.76	3.2 ± 2.6
Evacuation frequency (daily)	1.86 ± 1.72	1.54 ± 1.69	2 ± 1.69	1.77 ± 1.66	1.8 ± 1.69
Intestinal habits2	2.56 ± 1	2.22 ± 1.1	2.45 ± 1.05	2.33 ± 0.97	2.4 ± 1.03
Regular stool rate (%)	32.2	25.8	35.8	30	31

¹Includes abdominal discomfort, bloating or pain;

²Presence of mucus, sensation of incomplete evacuation and difficulty of evacuation. OB: Otilonium bromide.

Table 2 Comparison of treatment type by global discomfort index

Treatment	Ranks		Non-parametric tests
	Mean rank	Sum of ranks	Mann Whitney U	Wilcoxon Rank-Sum	Z	P-value
	30.2	845
Placebo vs OB 20 mg	26.8	751	345	751	-0.77	0.440
	33.9	949
Placebo vs OB 40 mg	23.1	647	241	647	-2.47	0.013
	35.6	997
Placebo vs OB 80 mg	21.4	599	193	599	-3.26	0.001
	30.4	851
OB 40 mg vs OB 80 mg	26.6	745	339	745	-0.87	0.390

OB: Otilonium bromide.

Table 3 Summary of all adverse events reported by treatment (safety population)

Treatment	Adverse event	Duration (d)	Intensity1	Serious	Outcome	Relation
Placebo	Flu/fever	12	1	No	Resolved	Not related
Placebo	Severe headache	3	2	No	Resolved	Not related
Placebo	Headache	14	2	No	Resolved	Probably related2
20 mg	Headache	5	1	No	Resolved	Possible related2
20 mg	Xerostomia	6	2	No	Resolved	Unlikely related2
20 mg	High fever	1	1	No	Resolved	Not related
20 mg	Pharyngitis	7	2	No	Resolved	Not related
20 mg	Pneumonia	17	2	No	Resolved	Not related
40 mg	Flu/fever	4	1	No	Resolved	Not related
40 mg	Asthma exacerbation	1	1	No	Resolved	Not related
40 mg	GI infection	6	2	No	Resolved	Not related
80 mg	Cystitis	19	1	No	Resolved	Not related
80 mg	Migraine attack1 nausea	1	1	No	Resolved	Not related
80 mg	Nausea	4	1	No	Resolved	Possible related2

¹Intensity was rated on a scale of 1-3 (1 = mild, 2 = moderate and 3 = severe);

²Adverse events subsequently confirmed as being related to treatment. OB: Otilonium bromide; GI: Gastrointestinal.