Trial · NCT03473561
Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea
NCT03473561, Phase 3, Completed, Abbott; results first posted 2023-11-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea. Trials, record NCT03473561. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03473561
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea
- NCT number
- NCT03473561
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 31 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Diarrhea, Infantile
- Interventions
- Racecadotril plus ORS
- First posted
- 2018-03-22
- Last updated
- 2023-11-24
- Results first posted
- 2023-11-24
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 5 days | Duration of diarrhea is defined by date and time of the evacuation of the final diarrheal stool derived from the daily diary |
| Secondary | Number of Recovered Subjects | 5 days | Number of recovered subjects |
| Secondary | Global Physician Assessment at the End of Treatment | 5 days | Scores 1-6 (Scores 1 and 2 are defined as success) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 5 days | hours | MEAN | |
| SECONDARY | Number of Recovered Subjects | 5 days | FA Sample | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Global Physician Assessment at the End of Treatment | 5 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Racecadotril Plus Standard Treatment Oral Rehydration Solution | 57.5 | Standard Error 5.79 | hours | |
| Number of Recovered Subjects | Racecadotril Plus Standard Treatment Oral Rehydration Solution | 23 | Participants | ||
| Global Physician Assessment at the End of Treatment | Racecadotril Plus Standard Treatment Oral Rehydration Solution | 25 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Racecadotril Plus Standard Treatment Oral Rehydration Solution | 31 | |
| Overall Study | COMPLETED | Racecadotril Plus Standard Treatment Oral Rehydration Solution | 31 | |
| Overall Study | NOT COMPLETED | Racecadotril Plus Standard Treatment Oral Rehydration Solution | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Racecadotril Plus Standard Treatment Oral Rehydration Solution | 3 | 31 | |
| other | Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Racecadotril Plus Standard Treatment Oral Rehydration Solution | 7 | 31 | |
| other | Laryngitis | Respiratory, thoracic and mediastinal disorders | Racecadotril Plus Standard Treatment Oral Rehydration Solution | 2 | 31 | |
| other | Bronchiolitis | Respiratory, thoracic and mediastinal disorders | Racecadotril Plus Standard Treatment Oral Rehydration Solution | 2 | 31 | |
| other | Dermatitis | Skin and subcutaneous tissue disorders | Racecadotril Plus Standard Treatment Oral Rehydration Solution | 2 | 31 | |
| serious | Bronchitis | Infections and infestations | Racecadotril Plus Standard Treatment Oral Rehydration Solution | 1 | 31 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Racecadotril Plus Standard Treatment Oral Rehydration Solution | 0 | 31 |
| Total, other adverse events | Racecadotril Plus Standard Treatment Oral Rehydration Solution | 16 | 31 |
| Total, serious adverse events | Racecadotril Plus Standard Treatment Oral Rehydration Solution | 1 | 31 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03473561
GET https://conductscience.org/api/trials/v1/NCT03473561/registered