Diarrhea
Conditions
Keywords
Diarrhea
Brief summary
The purpose of this study was to determine the efficacy of nitazoxanide suspension compared to placebo in treating prolonged diarrhea in children.
Interventions
DRUGNitazoxanide
Nitazoxanide Oral Suspension 100 mg/5 ml for patients aged 1-3 years twice daily for 3 days or Nitazoxanide Oral Suspension 200 mg/10 ml for patients aged 4-11 years twice daily for 3 days
Sponsors
Romark Laboratories L.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 11 Years
Healthy volunteers
No
Inclusion criteria
* Patients with diarrhea ≥3 days but \<30 days duration. * No visible blood in stool.
Exclusion criteria
* Use of any antibacterial, antiparasitic or antiviral drugs within 5 days of enrollment. * Females who are pregnant, suspected of being pregnant or breastfeeding. * Serious systemic disorders incompatible with the study. * History of hypersensitivity to nitazoxanide. * Patients in whom the possibility of receiving placebo and not being able to receive immediately an effective treatment will be incompatible with the severity of the patient's illness according to the investigator's judgment. * Patients known to have or suspected of having AIDS or other immune deficiencies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from first dose to resolution of symptoms | Up to 17 days | Resolution of symptoms defined as resolution of all gastrointestinal symptoms associated with prolonged diarrhea at enrollment including abdominal pain or tenderness, distention, etc. with the patient not requiring anti-motility or other palliative treatment. Symptom resolution must be maintained for at least 72 hours to be considered valid. |
Countries
Peru
Outcome results
None listed