Nitazoxanide for the Treatment of Prolonged Diarrhea in Children

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to determine the efficacy of nitazoxanide suspension compared to placebo in treating prolonged diarrhea in children.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Romark Laboratories L.C.
• Treatments: Nitazoxanide

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.