DiarrhoeaPhase 1/2ERADICATENCT06529497
Racecadotril Versus Standard Treatment in Decreasing the Duration of Acute Diarrhoea in Children
A Phase 1/2 study testing Racecadotril in people with Diarrhoea, run by Benazir Bhutto Hospital, Rawalpindi at 1 site in Pakistan.
Trial summary
Acute watery diarrhea is defined as the passage of 3 or more loose or liquid stools per day for 3 or more days but less than 14 days, including patients with mild to moderate dehydration per WHO classification. Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Diarrhoea
- What is being tested?
- Racecadotril
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Aug 2024to 2 Dec 2024
- Phase
- Phase 1/2
- 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 3 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hospitalized Patients with acute watery diarrhea of both genders who are
- Age: 03 months to 05 years
- Present in first 24 hours of onset of disease.
Who cannot join
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- Parenteral Diarrhea
- Chronic Diarrhea like Coeliac disease, Lactose intolerance
- Mal-absorption Syndromes
- Diarrhea related to food poisoning, dysentery as suggested by history
- Severe dehydration patents who are vitally unstable.
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- Diarrhea associated with measles.
- Persistent vomiting
- Abdominal distention
- Patients allergic to racecadotril
- Patients managed before enrolled to study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Racecadotril in Addition to Standard Treatment in Decreasing the Duration of Acute Diarrhea in Children as Compared to Standard of Treatment Alone
Acute watery diarrhea is defined as the passage of 3 or more loose or liquid stools per day for 3 or more days but less than 14 days, including patients with mild to moderate dehydration per WHO classification. The study's outcome variables are stool frequency, measured by the total number of stools passed during 24 and 48 hours from the initiation of treatment, and hospital duration, measured by the total duration of hospital stay in hours. The null hypothesis states that racecadotril combined with standard treatment has no effect on reducing the mean number of stools passed during 48 hours compared to standard treatment alone in pediatric patients with acute watery diarrhea, while the alternate hypothesis suggests that racecadotril combined with standard treatment will significantly reduce the mean number of stools passed during 48 hours compared to standard treatment alone in these patients.
- Conditions
- Diarrhoea
- Being tested
- Racecadotril
- Keywords
- Stool, Diarrhoea, gastroenteritis
- Medical subject headings
- Diarrhea, Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RacecadotrilDrug
Also called ORS+Zinc
The intervention group will receive racecadotril+ORS+Zinc
| Study group | Role | What they receive |
|---|---|---|
| treatment group receiving (racecadotril+ORS+Zinc) | Experimental | The intervention group will receive racecadotril+ORS+Zinc while the reference group will receive ORS+Zinc alone Receives: Drug: Racecadotril |
| the control group (receiving ORS + Zinc or standard treatment) | Active comparator | The intervention group will receive racecadotril+ORS+Zinc while the reference group will receive ORS+Zinc alone Receives: Drug: Racecadotril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool frequency
Total no. of stools passed during 24 and 48 hours from initiation of treatment will be compared between two groups
Measured: 48 hours
Secondary outcomes (1)
Hospital Duration
Total duration of hospital stay taken in hours
Measured: 48 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start2 Aug 2024
- Primary completion15 Nov 2024
- Study completion2 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrhoeaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benazir Bhutto Hospital, Rawalpindi
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Aqsa Jabeen, Benazir Bhutto Hospital, Rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529497
- Sponsor's protocol ID
- R-30/RMU
- Acronym
- ERADICATE
- Status last verified
- Jul 2024
- First submitted
- 26 Jul 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Racecadotril in Addition to Standard Treatment in Decreasing the Duration of Acute Diarrhea in Children as Compared to Standard of Treatment Alone
- ClinicalTrials.gov ID
- NCT06529497
- Acronym / sponsor ID
- ERADICATE / R-30/RMU
- Conditions
- Diarrhoea
- Keywords
- Stool, Diarrhoea, gastroenteritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Benazir Bhutto Hospital, RawalpindiOther government
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 31 Jul 2024 (actual)
- 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.
Acute watery diarrhea is defined as the passage of 3 or more loose or liquid stools per day for 3 or more days but less than 14 days, including patients with mild to moderate dehydration per WHO classification. The study's outcome variables are stool frequency, measured by the total number of stools passed during 24 and 48 hours from the initiation of treatment, and hospital duration, measured by the total duration of hospital stay in hours. The null hypothesis states that racecadotril combined with standard treatment has no effect on reducing the mean number of stools passed during 48 hours compared to standard treatment alone in pediatric patients with acute watery diarrhea, while the alternate hypothesis suggests that racecadotril combined with standard treatment will significantly reduce the mean number of stools passed during 48 hours compared to standard treatment alone in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group receiving (racecadotril+ORS+Zinc) | Experimental | Drug: RacecadotrilThe intervention group will receive racecadotril+ORS+Zinc while the reference group will receive ORS+Zinc alone |
| the control group (receiving ORS + Zinc or standard treatment) | Active comparator | Drug: RacecadotrilThe intervention group will receive racecadotril+ORS+Zinc while the reference group will receive ORS+Zinc alone |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Hospitalized Patients with acute watery diarrhea of both genders who are
Key exclusion criteria (11 listed)
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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: ORS+ZincThe intervention group will receive racecadotril+ORS+Zinc | Drug | the control group (receiving ORS + Zinc or standard treatment), treatment group receiving (racecadotril+ORS+Zinc) |
Primary outcome
Stool frequency
Time frame: 48 hours
Total no. of stools passed during 24 and 48 hours from initiation of treatment will be compared between two groups
1 secondary outcome
Hospital Duration
Time frame: 48 Hours
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 22 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Racecadotril in people with Diarrhoea, run by Benazir Bhutto Hospital, Rawalpindi at 1 site in Pakistan.
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 11 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 22 Sep 2026. 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 Pakistan. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Stool frequency (time frame: 48 hours). 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 22 Sep 2026.