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Nitazoxanide for the Treatment of Prolonged Diarrhea in Children

NCT ID: NCT01326338

Last Updated: 2011-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-05-31

Brief Summary

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

Detailed Description

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Conditions

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Diarrhea

Keywords

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Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nitazoxanide Suspension

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

Group Type EXPERIMENTAL

Nitazoxanide

Intervention Type 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

Placebo Suspension

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

Group Type PLACEBO_COMPARATOR

Nitazoxanide

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Alinia

Eligibility Criteria

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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.
Minimum Eligible Age

12 Months

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Romark Laboratories L.C.

INDUSTRY

Sponsor Role lead

Responsible Party

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Romark Laboratories, L.C.

Principal Investigators

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Nicolas Lopez, MD

Role: PRINCIPAL_INVESTIGATOR

Regional Hospital of Cajamarca

Locations

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Regional Hospital of Cajamarca

Cajamarca, , Peru

Site Status

Countries

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Peru

References

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Rossignol JF, Lopez-Chegne N, Julcamoro LM, Carrion ME, Bardin MC. Nitazoxanide for the empiric treatment of pediatric infectious diarrhea. Trans R Soc Trop Med Hyg. 2012 Mar;106(3):167-73. doi: 10.1016/j.trstmh.2011.11.007. Epub 2012 Jan 31.

Reference Type DERIVED
PMID: 22301075 (View on PubMed)

Other Identifiers

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RM02-3019

Identifier Type: -

Identifier Source: org_study_id