Nitazoxanide for the Treatment of Prolonged Diarrhea in Children

Phase 3

Completed

• Conditions: Diarrhea
• Interventions: Drug: Nitazoxanide

• Registration Number: NCT01326338
• Lead Sponsor: Romark Laboratories L.C.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2011-03
• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-29
• Last Update Submitted: 2011-03-29
• Study First Posted: 2011-03-30
• Last Update Posted: 2011-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Regional Hospital of Cajamarca; 🇵🇪 Cajamarca, Peru