DiarrheaPhase 4NCT00276328
Study to Evaluate Smecta® vs Placebo on the Time to Recovery Following an Acute Diarrhoea Episode in Adults
A Phase 4 study testing Diosmectite (Smecta®) in people with Diarrhea, run by Ipsen at 31 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate whether Smecta® is more effective than placebo with respect to time to recovery following an acute diarrhoea episode. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diarrhea
- What is being tested?
- Diosmectite (Smecta®)
- How many people
- 346 participants
- Where
- 31 sitesin 2 countries
- Study dates
- Jan 2005to Jul 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute diarrhoea episode defined as at least 3 watery stools per day for 48 hours or less
- Patient with, usually, normal bowel habits, i.e. at least 3 stools per week and no more than 3 stools per day
Who cannot join
- Gross blood, pus in the stools
- Fever >39ºC
- Other episode of acute watery diarrhoea within the last 30 days
- History of chronic diarrhoea or motor diarrhoea
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
Tunisia24 sites
Hopital régional de Ben Arous
Ben Arous, 2013
Hôpital des F.S.I.
La Marsa, 2070
Hôpital Régional de Menzel
Menzel Bourguiba, 7050
Hôpital Fattouma Bourguiba
Monastir, 5000
Hôpital Régional
Nabeul, 8000
Hôpital Hédi Chaker
Sfax, 3029
avenue du 20 mars 1956 - Cité Jawhara
Sousse, 4000
Cité Laouina
Sousse, 4000
rue Abou Baker Essadik
Sousse, 4000
rue Alexandre Dumas
Sousse, 4000
rue Sidi Sahloul - Hammam
Sousse, 4011
rue Ali Ibn Taleb - Messadine
Sousse, 4013
Avenue Habib Bourguiba - Kalaa Essghira
Sousse, 4021
Avenue Habib Bourguiba - Sidi Bou Ali
Sousse, 4040
Cité Sahloul, route principale, AFH No.9
Sousse, 4054
Hôpital Sahloul
Sousse, 4054
rue du 1 er juin - Kalaa Kebira
Sousse, 4060
Polyclinique Taoufik
Tunis, 1002
Rue Micipsa
Tunis, 1002
Hôpital Charles Nicolle
Tunis, 1006
Hôpital La Rabta
Tunis, 1007
Hôpital Habib Thameur
Tunis, 1008
Hôpital Militaire
Tunis, 1008
Polyclinique de la CNSS
Tunis, 1008
Morocco7 sites
Cabinet Médical, 50 rue Tata
Casablanca, 20000
Cabinet Medical, 17 Boulevard Bir Anzaran
Casablanca, 20200
Cabinet Médical, 12 rue Reaumur
Casablanca, 20200
Cabinet Médical, 94 boulevard du 11 janvier
Casablanca, 20200
Hopital Ibn Roched
Casablanca, 20200
Hôpital Ben Msick Sidi Othmane
Casablanca, 20200
Hôpital Avicenne
Rabat, 99
About this study
Official title: Efficacy of Diosmectite (Smecta®) in the Treatment of Acute Diarrhoea in Adults. A Multicentre, Randomised, Double Blind, Placebo Controlled, Parallel Groups Study.
The purpose of this study is to evaluate whether Smecta® is more effective than placebo with respect to time to recovery following an acute diarrhoea episode.
- Conditions
- Diarrhea
- Being tested
- Diosmectite (Smecta®)
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diosmectite (Smecta®)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recovery ie time (hours) from the first sachet intake to the first formed stool (this formed stool must have been followed by a non-watery stool)
Secondary outcomes (5)
Time (hours) from first sachet intake to the last watery stool
Number of stools and number of watery stools per 12 hour period
% of patients with recovery, per 12 hour period
% of patients with associated symptoms such as nausea, abdominal pain, anal irritation, per 12 hour period
Global evaluation of efficacy by the patient at Day 4 and Day 8 visits by a mean Visual Analogue Scale (VAS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startJan 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276328
- Sponsor's protocol ID
- 2-31-00250-009
- Status last verified
- Apr 2020
- First submitted
- 12 Jan 2006
- Last updated
- 28 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Diosmectite (Smecta®) in the Treatment of Acute Diarrhoea in Adults. A Multicentre, Randomised, Double Blind, Placebo Controlled, Parallel Groups Study.
- ClinicalTrials.gov ID
- NCT00276328
- Acronym / sponsor ID
- 2-31-00250-009
- Conditions
- Diarrhea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Study completion
- Jul 2006
- First posted
- 13 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether Smecta® is more effective than placebo with respect to time to recovery following an acute diarrhoea episode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute diarrhoea episode defined as at least 3 watery stools per day for 48 hours or less
- Patient with, usually, normal bowel habits, i.e. at least 3 stools per week and no more than 3 stools per day
Key exclusion criteria (4 listed)
- Gross blood, pus in the stools
- Fever >39ºC
- Other episode of acute watery diarrhoea within the last 30 days
- History of chronic diarrhoea or motor diarrhoea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diosmectite (Smecta®) | Drug | – |
Primary outcome
Time to recovery ie time (hours) from the first sachet intake to the first formed stool (this formed stool must have been followed by a non-watery stool)
5 secondary outcomes
Time (hours) from first sachet intake to the last watery stool
Number of stools and number of watery stools per 12 hour period
% of patients with recovery, per 12 hour period
% of patients with associated symptoms such as nausea, abdominal pain, anal irritation, per 12 hour period
Global evaluation of efficacy by the patient at Day 4 and Day 8 visits by a mean Visual Analogue Scale (VAS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
Related trials for Diarrhea
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
Not yet recruiting
Inactivated KAWAI Bacteria for Diarrhea Prevention During Pelvic Radiotherapy in Postoperative Cervical Cancer
Cervical Cancer
Enrolling by invitation
Hypernatremia Fluid Therapy in Childhood Diarrhoea
Hypernatremia, Acute Watery Diarrhea
Active, not recruitingPhase 3
Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
Carcinoid Syndrome, Carcinoid
Recruiting
Bacillus Clausii Versus Multistrain Probiotics for Acute Watery Diarrhea in Children
Acute Watery Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diosmectite (Smecta®) in people with Diarrhea, run by Ipsen at 31 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Tunisia, Morocco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recovery ie time (hours) from the first sachet intake to the first formed stool (this formed stool must have been followed by a non-watery stool). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.