Nitazoxanide for the Treatment of Prolonged Diarrhea in Children

Romark Laboratories

Status and phase: Completed; Phase 3

Conditions: Diarrhea

Treatments: Drug: Nitazoxanide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01326338

RM02-3019

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 12 months to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Nitazoxanide Suspension

Experimental group

Description:

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

Treatment:

Drug: Nitazoxanide

Placebo Suspension

Placebo Comparator group

Description:

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

Treatment:

Drug: Nitazoxanide