Status:
COMPLETED
Safety, Efficacy and Cost-effectiveness of Racecadotril in Children With Acute Diarrhea in Mexico
Lead Sponsor:
National Institute of Pediatrics, Mexico
Collaborating Sponsors:
Ferrer Laboratories
Conditions:
Diarrhea
Eligibility:
All Genders
1-24 years
Phase:
PHASE3
Brief Summary
Rationale: Acute diarrhea (AD) is still a significant morbidity-mortality problem worldwide. Although oral rehydration therapy is the cornerstone, its anti-diarrheal effect is a controversial subject....
Eligibility Criteria
Inclusion
- children ≥ 1 month of age and ≤ 24 months of age
- Acute diarrhea (defined as three or more watery or semi-watery bowel movements for at least one day lasting no more than 5 days before being admitted)
- For in hospital group: mild or moderate dehydration
- Signed informed consent letter
Exclusion
- previous use of oral antibiotics for more than 48 hours (during the two weeks before the trial
- previous use of anti-diarrheal medication (e.g.: bismuth subsalicylate, adsorbents, Loperamide, combinations)
- chronic pathologies (e.g.: cardiopathies, nephropathies, chronic gastrointestinal pathologies, endocrinopathies)
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
454 Patients enrolled
Trial Details
Trial ID
NCT01153854
Start Date
January 1 2007
End Date
December 1 2009
Last Update
June 30 2010
Active Locations (1)
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1
National Pediatric Institute
Mexico City, Mexico City, Mexico, 04530