Efficacy of Diosmectite (Smecta®) in the Symptomatic Treatment of Acute Diarrhoea in Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02704091
• Date of registration: 04/03/2016
• Prospective Registration: Yes
• Primary sponsor: Ipsen
• Public title: Efficacy of Diosmectite (Smecta®) in the Symptomatic Treatment of Acute Diarrhoea in Adults ADIASE
• Scientific title: Efficacy of Diosmectite (Smecta®) in the Symptomatic Treatment of Acute Diarrhoea in Adults. A Multicentre, Randomized, Double Blind Placebo Controlled, Parallel, Groups Study
• Date of first enrolment: March 17, 2016
• Target sample size: 858
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02704091
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 4

Countries of recruitment

Algeria, Czech Republic, Czechia, Egypt, Lebanon, Poland, Romania, Tunisia

Contacts

• Name: Ipsen Medical Director
• Affiliation: Ipsen

Key inclusion & exclusion criteria

Inclusion Criteria:

- Provision of written informed consent prior to any study related procedures

- 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. In Egypt, the
upper limit of age will be 60 years inclusive.

- 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 within the last 48 hours without associated alarm symptoms

- 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

- 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.

Exclusion criteria related to the acute diarrhoea episode:

- At least one of the following alarm symptoms

- Bloody diarrhoea*,

- pus in the stools*,

- fever =38°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

- other episode of acute watery diarrhoea within the previous 30 days,

- persistent diarrhoea, defined as acutely starting episode of diarrhoea lasting more
than 14 days,

- 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,

- 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:

- 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),

- intake of other prohibited drugs (as specified in the protocol)

- anti-diarrhoeal agent intake during the last month,

- any subject requiring repeated intake of a drug with a narrow therapeutic margin (as
specified in the protocol),

- history of hypersensitivity to diosmectite or its excipients or placebo components,

- 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),

- use of any investigational medication within the last 30 days before entering this
study,

- subject who previously entered in a clinical study within the past 30 days.

Other digestive exclusion criteria:

- History of gastric or intestinal resection, vagotomy,

- known digestive malabsorption disease, including coeliac disease

- known lactose intolerance,

- any suspicion of abdominal surgery need,

- known inflammatory bowel disease.

Other exclusion criteria:

- Known Human immunodeficiency virus (HIV) positive status,

- known or suspected immunosuppression,

- known severe renal insufficiency (including e-GFR not less than 45 mL/min) or hepatic
insufficiency,

- known endocrine disease or Type II Diabetes Mellitus with HBA1c more than 8,5% or
insulin-dependent diabetes,

- history of, or known current, problems with alcohol abuse and/or known drug addiction
(cocaine, heroin, hashish…),

- previous enrolment in this study,

- any mental condition rendering the subject unable to understand the nature, scope and
possible consequences of the study, and/or evidence of an uncooperative attitude.

- Pregnant or lactating women



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Acute Diarrhoea

Intervention(s)

Drug: Smecta placebo

Drug: Smecta

Primary Outcome(s)

Time to Recovery [Time Frame: From randomisation (Day 1) up to Day 9]

Secondary Outcome(s)

Percentage of Participants With Associated Symptoms, Per 12-Hour Period [Time Frame: From randomisation (Day 1) up to Day 9]

Time From Diarrhoea Onset to Recovery [Time Frame: From randomisation (Day 1) up to Day 9]

Abdominal Pain Intensity Scores, Per 12-Hour Period [Time Frame: From randomisation (Day 1) up to Day 9]

Number of Watery Stools, Per 12-Hour Period [Time Frame: From randomisation (Day 1) up to Day 9]

Number of Stools, Per 12-Hour Period [Time Frame: From randomisation (Day 1) up to Day 9]

Time From the First Study Treatment Intake to the Last Watery Stool [Time Frame: From randomisation (Day 1) up to Day 9]

Time From Diarrhoea Onset to First Formed Stool [Time Frame: From randomisation (Day 1) up to Day 9]

Secondary ID(s)

F-FR-00250-105

2015-001138-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/04/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02704091