DiarrhoeaPhase 3NCT00352989
Effectiveness of Smecta in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children
A Phase 3 study testing Smecta (Diosmectite), duration of treatment - 7 days in people with Diarrhoea, run by Ipsen at 19 sites in Malaysia.
Trial summary
The purpose of this study is to evaluate the effectiveness of Smecta at decreasing stool weight, when compared to placebo, in the treatment of acute diarrhoea in children. Read more about this study
- Who is it for?
- Ages 1 month to 36 months, men only
- Conditions the study is for
- Diarrhoea
- What is being tested?
- Smecta (Diosmectite), duration of treatment - 7 days
- How many people
- 302 participants
- Where
- 19 sitesMalaysia
- Study dates
- Jul 2006to 24 Mar 2007
- Phase
- Phase 3
- 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 1 month to 36 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- male
- acute watery diarrhoea defined as at least 3 watery stools per 24 hours
- duration of watery diarrhoea of less than 72 hours and with at least 1 watery stool for the last 12 hours
- dehydration signs requiring oral rehydration according to current WHO guidelines
Who cannot join
- severe dehydration that needs IV therapy
- presence of gross blood in stools
- fever >39 degrees Celsius
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Malaysia19 sites
Alor Setar Hospital
Alor Setar Kedah, 05100
Temerloh Hospital
Hospital Sultan Haji Ahmad Shah, Pahang, 28000
Ipoh Hospital
Ipoh - Perak, 30990
Kulim Hospital
Jalan Mahang, Kedah, 09000
Kajang Hospital
Jalan Semenyih, Kajang, 43000
Raja Perempuan Zainab II Hospital
Kelantan, 15000
Kluang Hospital
Kluang, Johor, 86000
Tengku Ampuan Rahimah Hospital
Kuala Selangor, 41200
Serdang Hospital
Kuala Selangor, 43300
Kuala Terengganu Hospital
Kuala Terengganu, 20400
Tengku Ampuan Afzan Hospital
Kuantan Pahang, 25100
Sarawak General Hospital
Kuching, 93586
Malacca Hospital
Malacca, 75400
Tuanku Jaafar Hospital
Negeri Sembilan, 70300
Pulau Pinang Hospital
Pulau Pinang, 10450
Seri Manjung Hospital
Seri Manjung, Perak, 28000
Sungai Petani Hospital
Sungai Petani, 08000
Taiping Hospital
Taiping Perak, 34000
Teluk Intan Hospital
Teluk Intan, Perak, 36000
About this study
Official title: Efficacy of Diosmectite (SMECTA®) in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children. A Phase IIIB, Placebo Controlled, Randomized, Double Blind, Parallel Groups, Multicenter Study.
The purpose of this study is to evaluate the effectiveness of Smecta at decreasing stool weight, when compared to placebo, in the treatment of acute diarrhoea in children.
- Conditions
- Diarrhoea
- Being tested
- Smecta (Diosmectite), duration of treatment - 7 days
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smecta (Diosmectite), duration of treatment - 7 daysDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative faecal output (g/kg of body weight)
Measured: 72 hours after first study drug intake
Secondary outcomes (8)
Cumulative faecal output (g)
Measured: 72 hours after the first study drug intake
Faecal output (g/kg of body weight) per day
Measured: 72 hours after the first study drug intake
Duration of watery diarrhoea (time of first study drug intake to watery diarrhoea disappearance)
Measured: 7 days after the first study drug intake
Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline)
Measured: 7 days after the first study drug intake
Percentage of body weight gain in comparison with body weight at inclusion
Measured: Till 7 days after the first study drug intake
Percentage of children with at least one formed stool (H12, H24, H36, H48, H60, H72, then daily until Day 7)
Measured: Till 7 days after first study drug intake
Daily until Day 7: stool frequency, watery stool number, formed stool number, soft stool number, percentage of patients with bottom skin irritation, percentage of patients with anal irritation, appetite on a 100mm visual analogue scale
Measured: Till 7 days after first study drug intake
Tolerance of Smecta (assessed via adverse event reporting)
Measured: Till 7 days after the last study drug intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2006 (estimated)
- Study startJul 2006
- Primary completion24 Mar 2007
- Study completion24 Mar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrhoeaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352989
- Sponsor's protocol ID
- 2-31-00250-101
- Status last verified
- Nov 2019
- First submitted
- 13 Jul 2006
- Last updated
- 22 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Diosmectite (SMECTA®) in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children. A Phase IIIB, Placebo Controlled, Randomized, Double Blind, Parallel Groups, Multicenter Study.
- ClinicalTrials.gov ID
- NCT00352989
- Acronym / sponsor ID
- 2-31-00250-101
- Conditions
- Diarrhoea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- 24 Mar 2007 (actual)
- Study completion
- 24 Mar 2007 (actual)
- First posted
- 17 Jul 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 the effectiveness of Smecta at decreasing stool weight, when compared to placebo, in the treatment of acute diarrhoea in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 1 month to 36 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- male
- acute watery diarrhoea defined as at least 3 watery stools per 24 hours
- duration of watery diarrhoea of less than 72 hours and with at least 1 watery stool for the last 12 hours
- dehydration signs requiring oral rehydration according to current WHO guidelines
Key exclusion criteria (3 listed)
- severe dehydration that needs IV therapy
- presence of gross blood in stools
- fever >39 degrees Celsius
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 |
|---|---|---|
| Smecta (Diosmectite), duration of treatment - 7 days | Drug | – |
Primary outcome
Cumulative faecal output (g/kg of body weight)
Time frame: 72 hours after first study drug intake
8 secondary outcomes
Cumulative faecal output (g)
Time frame: 72 hours after the first study drug intake
Faecal output (g/kg of body weight) per day
Time frame: 72 hours after the first study drug intake
Duration of watery diarrhoea (time of first study drug intake to watery diarrhoea disappearance)
Time frame: 7 days after the first study drug intake
Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline)
Time frame: 7 days after the first study drug intake
Percentage of body weight gain in comparison with body weight at inclusion
Time frame: Till 7 days after the first study drug intake
Percentage of children with at least one formed stool (H12, H24, H36, H48, H60, H72, then daily until Day 7)
Time frame: Till 7 days after first study drug intake
Daily until Day 7: stool frequency, watery stool number, formed stool number, soft stool number, percentage of patients with bottom skin irritation, percentage of patients with anal irritation, appetite on a 100mm visual analogue scale
Time frame: Till 7 days after first study drug intake
Tolerance of Smecta (assessed via adverse event reporting)
Time frame: Till 7 days after the last study drug intake
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 22 Nov 2019.
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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
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Smecta (Diosmectite), duration of treatment - 7 days in people with Diarrhoea, run by Ipsen at 19 sites in Malaysia.
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 4 inclusion and 3 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 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Malaysia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Cumulative faecal output (g/kg of body weight) (time frame: 72 hours after first study drug intake). 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 22 Nov 2019.