Trial · NCT03463512
Controlled Study to Evaluate the Efficacy and Safety of Racecadotril in Infants, Children and Adolescents With Acute Diarrhea
NCT03463512, Phase 3, Completed, Abbott; results first posted 2019-10-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Controlled Study to Evaluate the Efficacy and Safety of Racecadotril in Infants, Children and Adolescents With Acute Diarrhea. Trials, record NCT03463512. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03463512
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Controlled Study to Evaluate the Efficacy and Safety of Racecadotril in Infants, Children and Adolescents With Acute Diarrhea
- NCT number
- NCT03463512
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 124 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Diarrhea
- Interventions
- Racecadotril plus ORS, ORS
- First posted
- 2018-03-13
- Last updated
- 2019-10-23
- Results first posted
- 2019-10-23
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. Log-rank test was performed with a p-value \< 0.0001 |
| Secondary | Number of Recovered Subjects Per Treatment Group. | 5 days | Number of recovered subjects per treatment group. Recovery is defined as the evacuation of the first of two consecutive normal stools or no stool within 12 h within treatment period |
| Secondary | Number of Recovered Subjects as Defined by Global Physician Assessment of Success at the End of Treatment | 5 days | Globabl physician assessment used 6 scores with a score of 1 or 2 being regarded as treatment 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 | full analysis sample | hours | MEAN |
| SECONDARY | Number of Recovered Subjects Per Treatment Group. | 5 days | full analysis sample | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Recovered Subjects as Defined by Global Physician Assessment of Success at the End of Treatment | 5 days | full analysis sample | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
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 | 20.0 | Standard Deviation 2.2 | hours | |
| 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) | ORS (Standard Treatment) | 43.2 | Standard Deviation 3.4 | hours | |
| Number of Recovered Subjects Per Treatment Group. | Racecadotril Plus Standard Treatment Oral Rehydration Solution | 62 | Participants | ||
| Number of Recovered Subjects Per Treatment Group. | ORS (Standard Treatment) | 58 | Participants | ||
| Number of Recovered Subjects as Defined by Global Physician Assessment of Success at the End of Treatment | Racecadotril Plus Standard Treatment Oral Rehydration Solution | 62 | Participants | ||
| Number of Recovered Subjects as Defined by Global Physician Assessment of Success at the End of Treatment | ORS (Standard Treatment) | 60 | Participants |
Source ClinicalTrials.gov
Participant flow6
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 | 62 | |
| Overall Study | STARTED | ORS (Standard Treatment) | 62 | |
| Overall Study | COMPLETED | Racecadotril Plus Standard Treatment Oral Rehydration Solution | 62 | |
| Overall Study | COMPLETED | ORS (Standard Treatment) | 62 | |
| Overall Study | NOT COMPLETED | Racecadotril Plus Standard Treatment Oral Rehydration Solution | 0 | |
| Overall Study | NOT COMPLETED | ORS (Standard Treatment) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
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 | 62 |
| Total, all-cause mortality | ORS (Standard Treatment) | 0 | 62 |
| Total, other adverse events | Racecadotril Plus Standard Treatment Oral Rehydration Solution | 0 | 62 |
| Total, other adverse events | ORS (Standard Treatment) | 0 | 62 |
| Total, serious adverse events | Racecadotril Plus Standard Treatment Oral Rehydration Solution | 0 | 62 |
| Total, serious adverse events | ORS (Standard Treatment) | 0 | 62 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Racecadotril Plus Standard Treatment Oral Rehydration Solution vs ORS (Standard Treatment): Number of Recovered Subjects as Defined by Global Physician Assessment of Success at the End of Treatment | Trial comparisons |
| Racecadotril Plus Standard Treatment Oral Rehydration Solution vs ORS (Standard Treatment): Number of Recovered Subjects Per Treatment Group. | Trial comparisons |
| Racecadotril Plus Standard Treatment Oral Rehydration Solution vs ORS (Standard Treatment): deaths from any cause | Trial comparisons |
| Racecadotril Plus Standard Treatment Oral Rehydration Solution vs ORS (Standard Treatment): serious adverse events | Trial comparisons |
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/NCT03463512
GET https://conductscience.org/api/trials/v1/NCT03463512/registered