A study to assess efficacy of diosmectite (Smecta®) in the symptomatic treatment of acute diarrhoear in adults.

Phase 1

Conditions: Acute diarrhoea in adult
MedDRA version: 20.1 Level: LLT Classification code 10055955 Term: Acute diarrhoea System Organ Class: 100000004856
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2015-001138-10-PL

Lead Sponsor: Ipsen Pharma SAS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 854

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 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…),

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Secondary Objective: The secondary objectives of the study are as follows:<br> • To demonstrate that diosmectite efficacy is superior to placebo regarding other efficacy criteria.<br> • To assess the clinical tolerance of diosmectite versus placebo<br> ;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 Outcome Measures

Name	Time	Method

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