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Completed

NCT Number: NCT01326338

Nitazoxanide for the Treatment of Prolonged Diarrhea in Children

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

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Key information

Conditions

Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

12 month–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Regional Hospital of Cajamarca

Cajamarca, Peru

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nitazoxanide

Drug

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

Primary outcomes

  1. Time from first dose to resolution of symptoms

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Romark Laboratories L.C.

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Mar 30, 2011
Registry last updated
Mar 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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