Treatment of travellers' diarrhoea: zaldaride compared with loperamide and placebo.
OBJECTIVE
To compare zaldaride maleate, a calmodulin inhibitor with gastrointestinal antisecretory properties, with loperamide and a placebo in the treatment of travellers' diarrhoea.


METHODS
Randomized, double-blind, double-dummy study.


METHODS
Study clinic staffed by European residents on Nile cruise ships.


METHODS
Tourists (n = 436) who acquired travellers' diarrhoea during the Nile cruise.


METHODS
(1) Zaldaride 20 mg four times daily, (2) zaldaride 2 x 20 mg as initial loading dose followed by three doses of 20 mg on the first day and four doses of 20 mg on the second day, (3) loperamide 2 x 2 mg loading dose following by a flexible dosage of 2 mg after each unformed stool (maximum of 16 mg daily), (4) placebo.


METHODS
Number of unformed stools, rate of improvement of patients with diarrhoea, rate of relief from diarrhoea.


RESULTS
Among the 331 compliant and fully evaluated patients, the zaldaride with loading dose group showed no significant differences in cure rates from the loperamide group. For most parameters, zaldaride without a loading dose and the placebo resulted in significantly lower cure rates.


CONCLUSIONS
A zaldaride regimen including a loading dose was shown to be well tolerated and as effective as loperamide.
Silberschmidt
G
G
Division of Epidemiology and Prevention of Communicable Diseases, University of Zurich, Switzerland.
Schick
M T
MT
Steffen
R
R
Kilpatrick
M E
ME
Murphy
J R
JR
Oyofo
B A
BA
el-Etr
S
S
Gyurech
D
D
Mourad
A S
AS
Mathewson
J T
JT
D000293:Adolescent; D000328:Adult; D000368:Aged; D000930:Antidiarrheals / Q000008:administration & dosage* / Q000627:therapeutic use; D001562:Benzimidazoles / Q000008:administration & dosage* / Q000627:therapeutic use; D003967:Diarrhea / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008139:Loperamide / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D014195:Travel; D016896:Treatment Outcome
D000930:Antidiarrheals; D001562:Benzimidazoles; C052087:CGS 9343B; D008139:Loperamide