DiarrheaPhase 3NCT03463512
Controlled Study to Evaluate the Efficacy and Safety of Racecadotril in Infants, Children and Adolescents With Acute Diarrhea
A Phase 3 study testing Racecadotril plus ORS and ORS in people with Diarrhea, run by Abbott at 1 site in Russia.
Trial summary
Multicenter, open-label, controlled, randomized clinical study to evaluate the efficacy and safety of Racecadotril in infants, children and adolescents with acute diarrhea Read more about this study
- Who is it for?
- Ages 3 months to 17 years
- Conditions the study is for
- Diarrhea
- What is being tested?
- Racecadotril plus ORS and ORS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteRussia
- Study dates
- 29 Mar 2018to 10 Sep 2018
- 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 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Signed informed consent from one of the parent(s)/caregiver(s) or subject informed assent
- Children and adolescents, both genders, age from 3 months to < 18 years of age
- Confirmed diagnosis of acute diarrhea (defined as the passage of three or more unformed or liquid stools within the last 24 hours and lasting for less than three days)
- Females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug. Medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection, an intrauterine device, or an oral contraceptive taken within the past three months where the subject agrees to continue using during the study or to adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or spermicide
Who cannot join
- Known allergy to Racecadotril or any of its ingredients
- Subjects suffering from renal or hepatic impairment
- Subjects who need treatment for diarrhea other than ORS alone
- Subjects with fever > 39 degrees Celsius
- Subjects with bloody and/or purulent stools
- Subjects suffering from antibiotic-associated diarrhea, chronic diarrhea or iatrogenic diarrhea
Show all 20Show fewer
- Subjects with alternating bouts of diarrhea and constipation
- Diarrhea due to exacerbation of chronic gastrointestinal diseases such as irritable bowel syndrome, inflammatory 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 or galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption syndrome or sucrase isomaltase insufficiency or primary or secondary lactase insufficiency
- Subjects having received antibiotic treatment at any time within 30 days prior to inclusion into the study
- Subjects having received antidiarrheal drugs 48 hours prior to inclusion into the study
- Subjects with severe dehydration required for intravenous/parenteral rehydration
- Subjects who have 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 depending in the judgment of the investigator
- Intake of experimental drug within 30 days prior to study start
- Subjects with contraindications to ORS or for whom warnings/precautions of ORS apply
- Adolescents (≥ 60 kg) not able to swallow capsules
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
Russia1 site
Saint Petersburg State Budgetary Healthcare Institution "Municipal Outpatient Children Unit #45"
Saint Petersburg
About this study
Official title: Multicenter, Open-label, Controlled, Randomized Clinical Study to Evaluate the Efficacy and Safety of Racecadotril in Infants, Children and Adolescents With Acute Diarrhea
Multicenter, open-label, controlled, randomized clinical study to evaluate the efficacy and safety of Racecadotril in infants, children and adolescents with acute diarrhea
- Conditions
- Diarrhea
- Being tested
- Racecadotril plus ORS, ORS
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Racecadotril plus ORSDrug
Racecadotril plus ORS
ORSDrug
ORS
| Study group | Role | What they receive |
|---|---|---|
| Racecadotril plus standard treatment oral rehydration solution | Experimental | Not described Receives: Drug: Racecadotril plus ORS |
| ORS (standard treatment) | Active comparator | Not described Receives: Drug: 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.
Log-rank test was performed with a p-value < 0.0001
Measured: 5 days
Secondary outcomes (2)
Number of Recovered Subjects Per Treatment Group.
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
Measured: 5 days
Number of Recovered Subjects as Defined by Global Physician Assessment of Success at the End of Treatment
Globabl physician assessment used 6 scores with a score of 1 or 2 being regarded as treatment 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 posted13 Mar 2018
- Study start29 Mar 2018
- Primary completion10 Sep 2018
- Study completion10 Sep 2018
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 DiarrheaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463512
- Sponsor's protocol ID
- RACE3003
- Status last verified
- Oct 2019
- First submitted
- 5 Mar 2018
- Last updated
- 23 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label, Controlled, Randomized Clinical Study to Evaluate the Efficacy and Safety of Racecadotril in Infants, Children and Adolescents With Acute Diarrhea
- ClinicalTrials.gov ID
- NCT03463512
- Acronym / sponsor ID
- RACE3003
- Conditions
- Diarrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 10 Sep 2018 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Posted 23 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter, open-label, controlled, randomized clinical study to evaluate the efficacy and safety of Racecadotril in infants, children and adolescents with acute diarrhea
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Racecadotril plus standard treatment oral rehydration solution | Experimental | Drug: Racecadotril plus ORS |
| ORS (standard treatment) | Active comparator | Drug: ORS |
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Signed informed consent from one of the parent(s)/caregiver(s) or subject informed assent
- Children and adolescents, both genders, age from 3 months to < 18 years of age
- Confirmed diagnosis of acute diarrhea (defined as the passage of three or more unformed or liquid stools within the last 24 hours and lasting for less than three days)
- Females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug. Medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection, an intrauterine device, or an oral contraceptive taken within the past three months where the subject agrees to continue using during the study or to adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or spermicide
Key exclusion criteria (20 listed)
- Known allergy to Racecadotril or any of its ingredients
- Subjects suffering from renal or hepatic impairment
- Subjects who need treatment for diarrhea other than ORS alone
- Subjects with fever > 39 degrees Celsius
- Subjects with bloody and/or purulent stools
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 ORSRacecadotril plus ORS | Drug | Racecadotril plus standard treatment oral rehydration solution |
| ORSORS | Drug | ORS (standard treatment) |
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. Log-rank test was performed with a p-value < 0.0001
2 secondary outcomes
Number of Recovered Subjects Per Treatment Group.
Time frame: 5 days
Number of Recovered Subjects as Defined by Global Physician Assessment of Success 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 23 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 3 study testing Racecadotril plus ORS and ORS in people with Diarrhea, run by Abbott at 1 site in Russia.
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 4 inclusion and 20 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 23 Oct 2019. 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 Russia. 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 23 Oct 2019). 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 23 Oct 2019.