Trial | NCT01326338  Report issue

Title

Nitazoxanide for the Treatment of Prolonged Diarrhea in Children
Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Suspension in the Treatment of Prolonged Diarrhea in Children

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    100
The purpose of this study was to determine the efficacy of nitazoxanide suspension compared to placebo in treating prolonged diarrhea in children.
Study Started
Mar 31
2005
Primary Completion
May 31
2006
Study Completion
May 31
2006
Last Update
Mar 30
2011
Estimate

Drug Nitazoxanide

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

  • Other names: Alinia

Nitazoxanide Suspension Experimental

Nitazoxanide Oral Suspension 100 mg/5 ml for patients aged 1-3 years or Nitazoxanide Oral Suspension 200 mg/10 ml for patients aged 4-11 years

Placebo Suspension Placebo Comparator

Placebo Oral Suspension 5 ml for patients aged 1-3 years and Placebo Oral Suspension 10 ml for patients aged 4-11 years

Criteria 

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.
No Results Posted