A Phase 3 interventional study of Racecadotril plus ORS in Diarrhea, Infantile, sponsored by Abbott. Completed at 2 sites in Taiwan. Open to participants aged 3 Months to 60 Months. Per ClinicalTrials.gov, last updated 2023-11-24.
Sponsored by Abbott · Phase 3, Interventional, and Treatment
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
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.
26 studies on the registry are indexed under Diarrhea, Infantile; 5 are open to participants now.
This study's enrollment of 31 is below the median of 220 across 18 interventional studies indexed under Diarrhea, Infantile.
Browse Diarrhea, Infantile studies →Abbott is the lead sponsor of 361 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Drug: Racecadotril plus ORS
Drug page: Racecadotril
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.
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
Time frame: 5 days
Number of Recovered Subjects
Number of recovered subjects
Time frame: 5 days
Global Physician Assessment at the End of Treatment
Scores 1-6 (Scores 1 and 2 are defined as success)
Time frame: 5 days
| Milestone | Racecadotril Plus Standard Treatment Oral Rehydration Solution |
|---|---|
| Started | 31 |
| Completed | 31 |
| Not completed | 0 |
Duration of diarrhea is defined by date and time of the evacuation of the final diarrheal stool derived from the daily diary
| hours | Racecadotril Plus Standard Treatment Oral Rehydration Solution |
|---|---|
| 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 | 57.5 ± 5.79 |
Number of recovered subjects
| Participants | Racecadotril Plus Standard Treatment Oral Rehydration Solution |
|---|---|
| Number of Recovered Subjects | 23 |
Scores 1-6 (Scores 1 and 2 are defined as success)
| Participants | Racecadotril Plus Standard Treatment Oral Rehydration Solution |
|---|---|
| Global Physician Assessment at the End of Treatment | 25 |
Collected over 5 days plus 1 gap day. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Racecadotril Plus Standard Treatment Oral Rehydration Solution | 0/31 (0%) | 1/31 (3.2%) | 16/31 (51.6%) |
| Event | Racecadotril Plus Standard Treatment Oral Rehydration Solution |
|---|---|
| BronchitisInfections and infestations | 1/31 |
| Event | Racecadotril Plus Standard Treatment Oral Rehydration Solution |
|---|---|
| Upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders | 7/31 |
| DiarrhoeaGastrointestinal disorders | 3/31 |
| LaryngitisRespiratory, thoracic and mediastinal disorders | 2/31 |
| BronchiolitisRespiratory, thoracic and mediastinal disorders | 2/31 |
| DermatitisSkin and subcutaneous tissue disorders | 2/31 |
FA sample
| Age, Categorical(Participants) | Racecadotril Plus Standard Treatment Oral Rehydration Solution |
|---|---|
| <=18 years | 31 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Racecadotril Plus Standard Treatment Oral Rehydration Solution |
|---|---|
| Female | 13 |
| Male | 18 |
| Race (NIH/OMB)(Participants) | Racecadotril Plus Standard Treatment Oral Rehydration Solution |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 31 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Racecadotril Plus Standard Treatment Oral Rehydration Solution |
|---|---|
| Taiwan | 31 |
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Studies of the drug tested here: Racecadotril