Nitazoxanide for the Treatment of Prolonged Diarrhea in Children

Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326338
• Other study ID #: RM02-3019
• Status: Completed
• Phase: Phase 3
• First received: March 28, 2011
• Last updated: March 29, 2011
• Start date: March 2005
• Est. completion date: May 2006

Study information

• Verified date: March 2011
• Source: Romark Laboratories L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Peru: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 11 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea

Intervention

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

Locations

Country	Name	City	State
Peru	Regional Hospital of Cajamarca	Cajamarca

Sponsors (1)

Lead Sponsor	Collaborator
Romark Laboratories L.C.

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from first dose to resolution of symptoms	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.	Up to 17 days	No