The IMODIUM® Difference

Product: IMODIUM® Anti-Diarrheal
Clinical Support:
Amery W, Duyck F, Polak J, Van den Bouwhuysen G. A Multicentre Double-Blind Study In Acute Diarrhoea Comparing Loperamide (R 18553) With Two Common Antidiarrhoeal Agents and a Placebo. Current Therapeutic Research. 1975; 17 (3): 263- 270
The time span between the intake of the capsules (2X loperamide 2mg, diphenoxylate 2.5mg, clioquinol 200mg/phanquone 20mg, or placebo) and the first occurrence of stools within 24 hours, was used as the primary parameter for evaluation, since it was felt that this time would prove relevant as to the rapidity of anti-diarrhoeal activity. The median Time To First Unformed Stool (TTFUS) was 24 hours for the loperamide group, 3 hours for the clioquinol 200mg/phanquone 20mg group, and 2 hours for the diphenoxylate 2.5mg and placebo groups. A statistically significant difference was only seen with loperamide compared to the other groups, P<0.05. The number of patients without recurrent stool was statistically significant in the loperamide group compared to placebo at 1 hour (P<0.05) and remained significant

Limitations or Other Considerations
Nelemans FA, Zelvelder WG. A Double-Blind Placebo-Controlled Trial of Loperamide (Imodium) in Acute Diarrhoea. Journal of Drug Research. 1976; 2: 54- 59
Patients in the loperamide group (4mg single dose on onset) compared to placebo did not have a decrease in number of unformed stools requiring Reasec tablet use until 3 hours after administration of study drug compared to placebo. The difference between loperamide and placebo patients remained statistically significant from 3 hours to 24 hours. The median time to first liquid stool was more than 24 hours in the loperamide group and 10 hours in the control group.

Product: IMODIUM® Anti-Diarrheal
Clinical Support:
Amery W, Duyck F, Polak J, Van den Bouwhuysen G. A Multicentre Double-Blind Study In Acute Diarrhoea Comparing Loperamide (R 18553) With Two Common Antidiarrhoeal Agents and a Placebo. Current Therapeutic Research. 1975; 17 (3): 263- 270
The time span between the intake of the capsules (2X loperamide 2mg, diphenoxylate 2.5mg, clioquinol 200mg/phanquone 20mg, or placebo) and the first occurrence of stools within 24 hours, was used as the primary parameter for evaluation, since it was felt that this time would prove relevant as to the rapidity of anti-diarrhoeal activity. The median TTFUS was 24 hours for the loperamide group, 3 hours for the clioquinol 200mg/phanquone 20mg group, and 2 hours for the diphenoxylate 2.5mg and placebo groups. A statistically significant difference was only seen with loperamide compared to the other groups, P<0.05. The number of patients without recurrent stool was statistically significant in the loperamide group compared to placebo at 1 hour (P<0.05) and remained significant through the 24 hour period.

Nelemans FA, Zelvelder WG. A Double-Blind Placebo-Controlled Trial of Loperamide (Imodium) in Acute Diarrhoea. Journal of Drug Research. 1976; 2: 54- 59
Patients in the loperamide group (4mg single dose on onset) compared to placebo did not have a decrease in number of unformed stools requiring Reasec tablet use until 3 hours after administration of study drug compared to placebo. The difference between loperamide and placebo patients remained statistically significant from 3 hours to 24 hours. The median time to first liquid stool was more than 24 hours in the loperamide group and 10 hours in the control group.

DuPont MW, Luna AC, Mathewson JJ. Comparative Efficacy of Loperamide Hydrochloride and Bismuth Subsalicylate in the Management of Acute Diarrhea. American Journal of Medicine. 1990; 88 (S6A): 15S- 19S. {PROTOCOL 6-627 in CONNECT, and PROTOCOL 86-627S for ITT Analysis in CONNECT R0040296, PROTOCOL 86-627S2 Travelers’ Analysis R0007738}
The time to last unformed stool (TTLUS) is used as additional measure of efficacy. Comparing loperamide to bismuth subsalicylate in patients with acute diarrhea loperamide had statistically significant faster efficacy onset than bismuth subsalicylate when comparing the mean time to last unformed stool (TTLUS) in the first 24 hours. The mean TTLUS was 9.9 hours for loperamide and 17.3 hours for bismuth subsalicylate (p<0.0004). Median TTLUS was 3.4 hours for loperamide and 13.9 hours for bismuth subsalicylate. Time to control was significantly shorter for loperamide than bismuth subsalicylate (p=0.001).

Johnson PC, Ericsson CD, DuPont HL, Morgan DR, Bitsura JM, Wood LV. Comparison of Loperamide with Bismuth Subsalicylate for the Treatment of Acute Travelers' Diarrhea . Journal of the American Medical Association. 1986; 255 (6): 757- 760.
Loperamide compared to bismuth subsalicylate in patients with traveler’s diarrhea, loperamide was statistically significantly more effective at reducing the number of unformed stools than bismuth subsalicylate during all time points in the full 48 hour treatment interval, (P<.0004) for the zero- to four-hour treatment interval, four to 24 hours treatment interval (P<.002), and 24 to 48 treatment interval (P<.05). A greater number of subjects taking loperamide compared with those treated with bismuth subsalicylate had relief (P<.03) and improvement (P<.0001) of diarrhea. When results were analyzed by pathogen, if the time interval 0 to 24 hours is considered, loperamide-treated subjects had significantly fewer unformed stools than subjects in the bismuth subsalicylate groups according to etiologic category: enterotoxigenic E coli (P<.007), Shigella species (P<.03), other pathogens (P<.04), and no pathogen identified (P<.02).
The time span between the intake of the capsules (2X loperamide 2mg, diphenoxylate 2.5mg, clioquinol 200mg/phanquone 20mg, or placebo) and the first occurrence of stools within 24 hours, was used as the primary parameter for evaluation, since it was felt that this time would prove relevant as to the rapidity of anti-diarrhoeal activity. The median TTFUS was 24 hours for the loperamide group, 3 hours for the clioquinol 200mg/phanquone 20mg group, and 2 hours for the diphenoxylate 2.5mg and placebo groups. A statistically significant difference was only seen with loperamide compared to the other groups, P<0.05. The number of patients without recurrent stool was statistically significant in the loperamide group compared to placebo at 1 hour (P<0.05) and remained significant through the 24 hour period.