Diarrhea, InfantilePhase 3NCT03473561
Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea
A Phase 3 study testing Racecadotril plus ORS in people with Diarrhea, Infantile, run by Abbott at 2 sites in Taiwan.
Trial summary
This is a prospective, open-label, multicenter, single-arm study evaluating the efficacy and safety of Racecadotril the treatment of children aged 3 to 60 months suffering from acute diarrhea Read more about this study
- Who is it for?
- Ages 3 to 60 months
- Conditions the study is for
- Diarrhea, Infantile
- What is being tested?
- Racecadotril plus ORS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesTaiwan
- Study dates
- 25 Aug 2018to 8 Jan 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Signed informed consent from one of the parent(s)/legal representative(s)
- Subjects, both genders, aged 3 to 60 months
- Subjects with acute diarrhea (defined as the passage of three or more unformed or liquid stools within the last 24 hours and lasting for less than 3 days)
Who cannot join
- Known allergy to Racecadotril or any of its ingredients
- Subjects suffering from renal or hepatic impairment
- Subjects with fever > 39 degrees Celsius
- Subjects with bloody and/or purulent stools
- Subjects suffering from antibiotic (e.g. amoxicillin)-associated diarrhea, chronic diarrhea or iatrogenic diarrhea
- Subjects with alternating bouts of diarrhea and constipation
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- Diarrhea due to exacerbation of chronic gastrointestinal diseases such as irritable bowel syndrome, irritable bowel disease or pancreatic exocrine insufficiency
- Cystic fibrosis or coeliac disease
- Subjects suffering from prolonged or uncontrolled vomiting
- Subjects with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase isomaltase insufficiency
- Subjects having received antibiotic treatment at any time within 2 weeks prior to inclusion into the study
- Subjects having received antidiarrheal drugs 48 hours prior to inclusion into the study
- Subjects with severe dehydration requiring intravenous fluid, electrolyte replacement or hospitalization treatment
- Subject with a history of angioedema or who had reported angioedema with angiotensin converting enzyme inhibitors (such as captopril, enalapril, lisinopril, perindopril, ramipril)
- Subjects with combined diseases or medical situations that would prevent to be enrolled into the study, depending on the judgment of the investigator
- Intake of experimental drug within 30 days prior to study start
- Subjects with contraindications to ORS or susceptible to the warnings of ORS
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Linkou Chang Gung Memorial Hospital
Taipei
Mackay Memorial Hospital
Taipei
About this study
Official title: Efficacy and Safety of Racecadotril in the Treatment of Taiwanese Children Aged 3 to 60 Months Suffering From Acute Diarrhea: A Prospective, Open-label, Multicenter, Single-arm Study.
This is a prospective, open-label, multicenter, single-arm study evaluating the efficacy and safety of Racecadotril the treatment of children aged 3 to 60 months suffering from acute diarrhea
Read the detailed description
Subjects presenting with acute diarrhea will be evaluated for eligibility. If eligible, demographics, number of stools during the last 12 hours will be assessed as baseline values. On Day 1, the subject will start with study treatment.
Subjects will be treated with Racecadotril three times daily according to the body weight dose requirement on an out-patient basis for maximum 5 days in addition to ORS. ORS will be prescribed by the investigator. The parent(s)/caregiver(s)/legal representative(s) will be instructed to stop treatment when the patient recovered. Recovery is defined by the evacuation of the first of two consecutive normal stools or no stool within 12 hours. In the evening of each day, the parent(s)/caregiver(s)/legal representative(s) will fill in their diaries, documenting date and time of each individual stool, the stool consistency of each stool, ORS amount and the study drug intake. AEs are to be reported on an ongoing basis.
The last dose of study drug intake will be the morning dose of day 6, if not recovered earlier. The parent(s)/caregiver(s)/legal representative(s) will visit the site for the end of study visit of the child. Data on vital signs, AEs, physical examination and concomitant medication will be collected. The parent(s)/caregiver(s)/legal representative(s) will return the diaries and unused medication.
A phone call contact will be performed 5-7 days after the end of the treatment period or recovery for the safety follow-up.
- Conditions
- Diarrhea, Infantile
- Being tested
- Racecadotril plus ORS
- Medical subject headings
- Diarrhea, Infantile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Racecadotril plus ORSDrug
1.5 mg/kg of Racecadotril will be administered, 3 times daily, via the oral route (in addition to standard treatment i.e. oral rehydration solution).
In infants less than 9 kg: one 10 mg sachet 3 times daily. In infants from 9 kg to < 13 kg: two 10 mg sachets 3 times daily. In children from 13 kg to 27 kg: one 30 mg sachet 3 times daily. In children of more than 27 kg: two 30 mg sachets 3 times daily.
| Study group | Role | What they receive |
|---|---|---|
| Racecadotril plus standard treatment oral rehydration solution | Experimental | Racecadotril Infants Granules for Oral Suspension 10 mg (in addition to standard treatment i.e. oral rehydration solution) Racecadotril Children Granules for Oral Suspension 30 mg (in addition to standard treatment i.e. oral rehydration solution) Receives: Drug: Racecadotril plus ORS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Diarrhea (Hours) Between the Start of Treatment Until Last Diarrheal/Watery Stool Before Recovery or End of Study Treatment (Treatment Duration Maximal 5 Days
Duration of diarrhea is defined by date and time of the evacuation of the final diarrheal stool derived from the daily diary
Measured: 5 days
Secondary outcomes (2)
Number of Recovered Subjects
Number of recovered subjects
Measured: 5 days
Global Physician Assessment at the End of Treatment
Scores 1-6 (Scores 1 and 2 are defined as success)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start25 Aug 2018
- Primary completion8 Jan 2020
- Study completion8 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diarrhea, InfantileStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473561
- Sponsor's protocol ID
- RACE3002
- Status last verified
- Feb 2023
- First submitted
- 12 Mar 2018
- Last updated
- 24 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Racecadotril in the Treatment of Taiwanese Children Aged 3 to 60 Months Suffering From Acute Diarrhea: A Prospective, Open-label, Multicenter, Single-arm Study.
- ClinicalTrials.gov ID
- NCT03473561
- Acronym / sponsor ID
- RACE3002
- Conditions
- Diarrhea, Infantile
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2018 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Posted 24 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, open-label, multicenter, single-arm study evaluating the efficacy and safety of Racecadotril the treatment of children aged 3 to 60 months suffering from acute diarrhea
Detailed description
Subjects presenting with acute diarrhea will be evaluated for eligibility. If eligible, demographics, number of stools during the last 12 hours will be assessed as baseline values. On Day 1, the subject will start with study treatment.
Subjects will be treated with Racecadotril three times daily according to the body weight dose requirement on an out-patient basis for maximum 5 days in addition to ORS. ORS will be prescribed by the investigator. The parent(s)/caregiver(s)/legal representative(s) will be instructed to stop treatment when the patient recovered. Recovery is defined by the evacuation of the first of two consecutive normal stools or no stool within 12 hours. In the evening of each day, the parent(s)/caregiver(s)/legal representative(s) will fill in their diaries, documenting date and time of each individual stool, the stool consistency of each stool, ORS amount and the study drug intake. AEs are to be reported on an ongoing basis.
The last dose of study drug intake will be the morning dose of day 6, if not recovered earlier. The parent(s)/caregiver(s)/legal representative(s) will visit the site for the end of study visit of the child. Data on vital signs, AEs, physical examination and concomitant medication will be collected. The parent(s)/caregiver(s)/legal representative(s) will return the diaries and unused medication.
A phone call contact will be performed 5-7 days after the end of the treatment period or recovery for the safety follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Racecadotril plus standard treatment oral rehydration solution | Experimental | Drug: Racecadotril plus ORSRacecadotril Infants Granules for Oral Suspension 10 mg (in addition to standard treatment i.e. oral rehydration solution) Racecadotril Children Granules for Oral Suspension 30 mg (in addition to standard treatment i.e. oral rehydration solution) |
Who may qualify
- Ages
- 3 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Signed informed consent from one of the parent(s)/legal representative(s)
- Subjects, both genders, aged 3 to 60 months
- Subjects with acute diarrhea (defined as the passage of three or more unformed or liquid stools within the last 24 hours and lasting for less than 3 days)
Key exclusion criteria (17 listed)
- Known allergy to Racecadotril or any of its ingredients
- Subjects suffering from renal or hepatic impairment
- Subjects with fever > 39 degrees Celsius
- Subjects with bloody and/or purulent stools
- Subjects suffering from antibiotic (e.g. amoxicillin)-associated diarrhea, chronic diarrhea or iatrogenic diarrhea
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 |
|---|---|---|
| Racecadotril plus ORS1.5 mg/kg of Racecadotril will be administered, 3 times daily, via the oral route (in addition to standard treatment i.e. oral rehydration solution). In infants less than 9 kg: one 10 mg sachet 3 times daily. In infants from 9 kg to < 13 kg: two 10 mg sachets 3 times daily. In children from 13 kg to 27 kg: one 30 mg sachet 3 times daily. In children of more than 27 kg: two 30 mg sachets 3 times daily. | Drug | Racecadotril plus standard treatment oral rehydration solution |
Primary outcome
Duration of Diarrhea (Hours) Between the Start of Treatment Until Last Diarrheal/Watery Stool Before Recovery or End of Study Treatment (Treatment Duration Maximal 5 Days
Time frame: 5 days
Duration of diarrhea is defined by date and time of the evacuation of the final diarrheal stool derived from the daily diary
2 secondary outcomes
Number of Recovered Subjects
Time frame: 5 days
Global Physician Assessment at the End of Treatment
Time frame: 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 Racecadotril plus ORS in people with Diarrhea, Infantile, run by Abbott at 2 sites in Taiwan.
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 3 inclusion and 17 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 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
Yes. Results are posted in the registry (first posted 24 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Diarrhea (Hours) Between the Start of Treatment Until Last Diarrheal/Watery Stool Before Recovery or End of Study Treatment (Treatment Duration Maximal 5 Days (time frame: 5 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 24 Nov 2023.