Acute DiarrheaPhase 4NCT01577043
Efficacy of Racecadotril in Acute Watery Diarrhea in Children
A Phase 4 study testing Racecadotril in people with Acute Diarrhea and Acute Gastroenteritis, run by Centro Pediatrico Albina de Patino at 1 site in Bolivia.
Trial summary
The purpose of this study is to determine the effect of racecadotril in acute watery diarrhea in children. The investigators will evaluate the effect of product versus placebo. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Acute Diarrhea, Acute Gastroenteritis
- What is being tested?
- Racecadotril
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteBolivia
- Study dates
- Sep 2011to Apr 2012
- 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 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Acute watery diarrhea
Who cannot join
- Severe malnourishment
- Severe dehydration
- Systemic infections
- Coinfections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Racecadotril in the Management of Acute Watery Diarrhea in Children
The purpose of this study is to determine the effect of racecadotril in acute watery diarrhea in children. The investigators will evaluate the effect of product versus placebo.
Read the detailed description
Background: Treatment of acute diarrhea is based on the following various oral rehydration management guidelines. Lately other drugs currently under investigation as antisecretory drugs to shorten the diarrheal episode and can be used safely in children.
Objectives: To evaluate the effect of racecadotril in the treatment of children under 5 years of age with acute diarrhea.
Methods: A randomized clinical trial, controlled, double-blind. The investigators will have two groups of patients: One group will receive racecadotril plus oral rehydration and the other one will receive placebo plus oral rehydration; the parameters of evaluation are going to be the duration of diarrheal episode, number of stools by day, weight of stool, nutritional state.
- Conditions
- Acute Diarrhea, Acute Gastroenteritis
- Being tested
- Racecadotril, Placebo
- Keywords
- acute diarrhea, Racecadotril, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RacecadotrilDrug
Also called Hidrasec
Racecadotril, 30 mg per sachet, dosage 1.5 mg./kg./day
PlaceboOther
cornstarch powder diluted in distilled water, dosage 2.5 ml per dose
| Study group | Role | What they receive |
|---|---|---|
| Racecadotril | Active comparator | intestinal antisecretory Receives: Drug: Racecadotril |
| cornstach solution | Placebo comparator | Cornstarch powder diluted in distilled water Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of diarrheal episode
Duration of diarrheal episode, time in which the watery stools will be normalized, an expected average of 5 days
Measured: five days
Secondary outcomes (3)
Duration of hospitalization
Participants was followed for the duration of hospitalization, we expected average of 5 days
Measured: five days
Weight of stool
We expected the weight of the stool will diminish by about 5 days
Measured: five days
Frequency of stool per day
We expected the frequency of stool will diminish by about 5 days
Measured: five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startSep 2011
- Primary completionJan 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DiarrheaStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Pediatrico Albina de Patino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Grandy, Centro Pediatrico Albina de Patino
- Investigators
- Giuseppe Grandy, MD MSc, Study director, Centro Pediatrico Albina de PtinoRichard Soria, MD, Principal investigator, Centro Pediatrico Albina de PatinoJackeline Torrez, MD, Study chair, Centro Pediatrico Albina de Patino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577043
- Sponsor's protocol ID
- protracec2011
- Status last verified
- Jun 2011
- First submitted
- 11 Apr 2012
- Last updated
- 13 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Racecadotril in the Management of Acute Watery Diarrhea in Children
- ClinicalTrials.gov ID
- NCT01577043
- Acronym / sponsor ID
- protracec2011
- Conditions
- Acute Diarrhea, Acute Gastroenteritis
- Keywords
- acute diarrhea, Racecadotril, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Centro Pediatrico Albina de PatinoUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 13 Apr 2012 (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 determine the effect of racecadotril in acute watery diarrhea in children. The investigators will evaluate the effect of product versus placebo.
Detailed description
Background: Treatment of acute diarrhea is based on the following various oral rehydration management guidelines. Lately other drugs currently under investigation as antisecretory drugs to shorten the diarrheal episode and can be used safely in children.
Objectives: To evaluate the effect of racecadotril in the treatment of children under 5 years of age with acute diarrhea.
Methods: A randomized clinical trial, controlled, double-blind. The investigators will have two groups of patients: One group will receive racecadotril plus oral rehydration and the other one will receive placebo plus oral rehydration; the parameters of evaluation are going to be the duration of diarrheal episode, number of stools by day, weight of stool, nutritional state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Racecadotril | Active comparator | Drug: Racecadotrilintestinal antisecretory |
| cornstach solution | Placebo comparator | Other: PlaceboCornstarch powder diluted in distilled water |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Acute watery diarrhea
Key exclusion criteria (4 listed)
- Severe malnourishment
- Severe dehydration
- Systemic infections
- Coinfections
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 |
|---|---|---|
| RacecadotrilAlso: HidrasecRacecadotril, 30 mg per sachet, dosage 1.5 mg./kg./day | Drug | Racecadotril |
| Placebocornstarch powder diluted in distilled water, dosage 2.5 ml per dose | Other | cornstach solution |
Primary outcome
Duration of diarrheal episode
Time frame: five days
Duration of diarrheal episode, time in which the watery stools will be normalized, an expected average of 5 days
3 secondary outcomes
Duration of hospitalization
Time frame: five days
Weight of stool
Time frame: five days
Frequency of stool per day
Time frame: five days
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 13 Apr 2012.
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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.
Giuseppe Grandy, MD MSc study director
Centro Pediatrico Albina de Ptino
Richard Soria, MD principal investigator
Centro Pediatrico Albina de Patino
Jackeline Torrez, MD study chair
Centro Pediatrico Albina de Patino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Racecadotril in people with Acute Diarrhea and Acute Gastroenteritis, run by Centro Pediatrico Albina de Patino at 1 site in Bolivia.
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 1 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 13 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bolivia. 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. Some participants in this study may receive a placebo. 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?
Duration of diarrheal episode (time frame: five days). 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 13 Apr 2012.