Efficacy of Diosmectite (Smecta®) in the Symptomatic Treatment of Acute Diarrhoea in Adults (ADIASE)
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| ClinicalTrials.gov Identifier: NCT02704091 |
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Recruitment Status :
Completed
First Posted : March 9, 2016
Results First Posted : April 24, 2020
Last Update Posted : November 5, 2020
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Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
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Brief Summary:
The purpose of the study is to demonstrate that diosmectite efficacy is superior to placebo regarding time to recovery of an acute diarrhoea episode presumed of infectious origin in adult subjects.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Diarrhoea | Drug: Smecta Drug: Smecta placebo | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 858 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Efficacy of Diosmectite (Smecta®) in the Symptomatic Treatment of Acute Diarrhoea in Adults. A Multicentre, Randomized, Double Blind Placebo Controlled, Parallel, Groups Study |
| Actual Study Start Date : | March 17, 2016 |
| Actual Primary Completion Date : | April 8, 2019 |
| Actual Study Completion Date : | April 8, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Smecta
2 sachets, three times a day (TID), during 5 to 9 days
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Drug: Smecta
Other Name: Diosmectite Beaufour |
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Placebo Comparator: Smecta placebo
2 sachets of placebo, TID, during 5 to 9 days
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Drug: Smecta placebo |
Primary Outcome Measures :
- Time to Recovery [ Time Frame: From randomisation (Day 1) up to Day 9 ]Time to recovery was defined as the time from the first study treatment intake recorded in the electronic case report form (eCRF) to the first formed stool followed by a non-watery stool, recorded in the DEB. Results are presented as median time to recovery, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn without recovery or ending the study without recovery were censored (not responders) at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).
Secondary Outcome Measures :
- Time From Diarrhoea Onset to Recovery [ Time Frame: From randomisation (Day 1) up to Day 9 ]The event of diarrhoea onset (i.e. loose or watery stool) was recorded in the eCRF and the event of recovery (i.e. first formed stool followed by a non-watery stool) was recorded in the DEB. Results are presented as median time from diarrhoea onset to recovery, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn without recovery or ending the study without recovery were censored (not responders) at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).
- Time From Diarrhoea Onset to First Formed Stool [ Time Frame: From randomisation (Day 1) up to Day 9 ]The event of diarrhoea onset (i.e. loose or watery stool) was recorded in the eCRF and the event of first formed stool was recorded in the DEB. Results are presented as median time from diarrhoea onset to first formed stool, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn with no formed stool or ending the study with no formed stool were censored at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).
- Time From the First Study Treatment Intake to the Last Watery Stool [ Time Frame: From randomisation (Day 1) up to Day 9 ]The event of first study treatment intake was recorded in the eCRF and the event of last watery stool was recorded in the DEB. Results are presented as median time from first study treatment intake to last watery stool, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn with no watery stool or ending the study with no watery stool were censored at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).
- Number of Stools, Per 12-Hour Period [ Time Frame: From randomisation (Day 1) up to Day 9 ]Number of stools, per 12-hour period, was recorded in the DEB.
- Number of Watery Stools, Per 12-Hour Period [ Time Frame: From randomisation (Day 1) up to Day 9 ]Number of watery stools, per 12-hour period, was recorded in the DEB.
- Percentage of Participants With Associated Symptoms, Per 12-Hour Period [ Time Frame: From randomisation (Day 1) up to Day 9 ]Percentage of participants with associated symptoms (at least 1 symptom of nausea, vomiting, abdominal pain or anal irritation) per 12-hour period is presented. Nausea, vomiting, abdominal pain and anal irritation were recorded in the DEB.
- Abdominal Pain Intensity Scores, Per 12-Hour Period [ Time Frame: From randomisation (Day 1) up to Day 9 ]Abdominal pain intensity per 12-hour period was recorded in the DEB. Abdominal pain intensity was rated with a 5-point ordinal scale: 0 = absent, 1= mild, 2 =moderate, 3 = severe, 4= very severe. Higher scores indicate a worse outcome. The median abdominal pain intensity score for each 12-hour period is presented.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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:
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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:
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704091
Locations
Show 71 study locations
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Ipsen Medical Director | Ipsen |
Study Documents (Full-Text)
Documents provided by Ipsen:
Documents provided by Ipsen:
Study Protocol [PDF] January 7, 2019
Statistical Analysis Plan [PDF] July 15, 2019
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT02704091 |
| Other Study ID Numbers: |
F-FR-00250-105 2015-001138-10 ( EudraCT Number ) |
| First Posted: | March 9, 2016 Key Record Dates |
| Results First Posted: | April 24, 2020 |
| Last Update Posted: | November 5, 2020 |
| Last Verified: | November 2020 |
Additional relevant MeSH terms:
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Diarrhea Signs and Symptoms, Digestive |