Acute diarrhoea in adult MedDRA version: 20.1 Level: LLT Classification code 10055955 Term: Acute diarrhoea System Organ Class: 100000004856
Conditions
Sponsors
Ipsen Pharma SAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Provision of written informed consent prior to any study related procedures, (2) male or female subject (outpatient) legally considered as an adult (age of majority). In Czech Republic the upper limit of age will be 70 years inclusive. (3) subject has a diagnosis of acute diarrhoea presumed of infectious origin, defined as: - the passage of 3 or more unformed loose or watery stools (rated according to the Bristol scale) per day without associated alarm symptoms* - having started within 48 hours before Visit 1 (first study drug intake time). (4) subject has, usually, normal bowel habits, (Rome III criteria) ** , i.e. at least 3 stools per week and no more than 3 stools per day, (5) subject must be willing and able to comply with study restrictions and willing to return to the clinic for the follow up evaluation(s) as specified in the protocol. *Symptoms considered as alarm symptoms are identified in the exclusion criteria (1) **Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional Bowel Disorders. Gastroenterology 2006; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 754 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: Exclusion criteria related to the acute diarrhoea episode: (1) At least one of the following alarm symptoms* • bloody diarrhoea*, • pus in the stools*, • fever =38.0°C*, • moderate or severe dehydration according to World Health Organisation (WHO) definition, requiring intravenous (IV) rehydration*, • repeated vomiting* • persistent abdominal pain* *These symptoms are considered as alarm symptoms (2) other episode of acute watery diarrhoea within the previous 30 days, (3) persistent diarrhoea, defined as acutely starting episode of diarrhoea lasting more than 14 days, (4) history of chronic diarrhoea (Rome III criteria); i.e. 3 or more loose or watery stools per day for at least 12 weeks, consecutive or not, in the preceding 12 months, (5) traveller's diarrhoea defined as a diarrhoeal episode due to contamination experienced by subjects having travelled in at risk countries, or coming from abroad and experiencing locally an acute diarrhoea episode, occurring usually within the first 2 weeks of the stay in a foreign environment. Exclusion criteria related to drugs: (6) Diarrhoea suspected to be induced by drug for example: • antibiotic therapy, including Clostridium difficile-induced diarrhoea, within 1 week before entry in the study, • laxative agent • thyroid hormone (at a nonstabilised dosing), • colchicine intake, etc. (7) anti-diarrhoeal agent intake during the last month, (8) any subject requiring repeated intake of a drug with a narrow therapeutic margin (for example, digoxin, theophylline, etc.), (9) history of hypersensitivity to diosmectite or its excipients or placebo components, (10) subject likely to require treatment during the study with drugs that are not permitted by the study protocol (for example, antibiotic agent, anti-diarrhoeal agent, antiemetic drug, antispasmodic drug), (11) use of any investigational medication within the last 30 days before entering this study, (12) subject who previously entered in a clinical study within the past 30 days. Other digestive exclusion criteria: (13) History of gastric or intestinal resection, vagotomy, (14) known digestive malabsorption disease, including coeliac disease (15) known lactose intolerance, (16) any suspicion of abdominal surgery need, (17) known inflammatory bowel disease. Other exclusion criteria: (18) Known Human immunodeficiency virus (HIV) positive status, (19) known or suspected immunosuppression, (20) known severe renal or hepatic insufficiency, (21) known endocrine disease or insulin-dependent diabetes, (22) history of, or known current, problems with alcohol abuse and/or known drug addiction (cocaine, heroin, hashish…),
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives of the study are as follows: • To demonstrate that diosmectite efficacy is superior to placebo regarding other efficacy criteria. • To assess the clinical tolerance of diosmectite versus placebo ;Main Objective: The primary objective of the study is to demonstrate that diosmectite efficacy is superior to placebo regarding the time to recovery of an acute diarrhoea episode presumed of infectious origin in adult subjects.;Primary end point(s): The primary efficacy endpoint is the time to recovery, defined as time from the 1st study treatment intake recorded in the electronic case report form (eCRF) to the first formed stool followed by a nonwatery stool, recorded in the Diary Evaluation Booklet (DEB). Consistency will be rated according to the Bristol scale.;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are the following: (a) abdominal pain intensity (rated with a 5-point ordinal scale: 0 = absent, 1=mild, 2 =moderate, 3 = severe, 4= very severe) per 12-hour period, recorded in the DEB (b) time (hours, minutes) from diarrhoea onset to recovery defined as first formed stool followed by a nonwatery stool, recorded in the DEB (c) time (hours, minutes) from first watery stool to the first formed stool, recorded in the DEB (d) time (hours, minutes) from the 1st study treatment intake recorded in the eCRF to the last watery stool recorded in the DEB, (e) number of stools, per 12-hour period, recorded in the DEB (f) number of watery stools, per 12-hour period, recorded in the DEB (g) percentage of subjects with associated symptoms such as nausea, vomiting, abdominal pain and anal irritation, per 12-hour period, recorded in the DEB*. *Nausea, vomiting, abdominal pain and anal irritation, per 12-hour period will be recorded in the DEB. The percentage of subjects will not be recorded in the DEB. The safety and tolerability of diosmectite will be assessed throughout the study by evaluating adverse events (AEs) recorded from subject from the time that the subject gives informed consent until 7 days after the end of the study treatment, vital signs measurements, and physical examination results, and concomitant medication usage. ; Timepoint(s) of evaluation of this end point: Throughout the study Safety: Throughout the study until 7 days after the end of the study treatment | — |
Countries
Algeria, Czech Republic, Egypt, Lebanon, Poland, Romania, Tunisia
Contacts
Public ContactADIASE - helpdesk
KCR S.A.
Outcome results
None listed