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Nitazoxanide for the Treatment of Prolonged Diarrhea in Children

This study has been completed.
Sponsor:
Information provided by:
Romark Laboratories L.C.
ClinicalTrials.gov Identifier:
NCT01326338
First received: March 28, 2011
Last updated: March 29, 2011
Last verified: March 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Diarrhea
 Drug: Nitazoxanide
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Suspension in the Treatment of Prolonged Diarrhea in Children

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Further study details as provided by Romark Laboratories L.C.:

Primary Outcome Measures:
  • Time from first dose to resolution of symptoms [ Time Frame: Up to 17 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 100
Study Start Date: March 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
 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
Other Name: Alinia
Placebo Comparator: 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
 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
Other Name: Alinia

  Eligibility

Ages Eligible for Study:   12 Months to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01326338

Locations
Peru
Regional Hospital of Cajamarca
Cajamarca, Peru
Sponsors and Collaborators
Romark Laboratories L.C.
Investigators
Principal Investigator: Nicolas Lopez, MD Regional Hospital of Cajamarca
  More Information

No publications provided by Romark Laboratories L.C.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Celine Rossignol, MS, Romark Laboratories, L.C.
ClinicalTrials.gov Identifier: NCT01326338     History of Changes
Other Study ID Numbers: RM02-3019
Study First Received: March 28, 2011
Last Updated: March 29, 2011
Health Authority: Peru: Ministry of Health

Keywords provided by Romark Laboratories L.C.:
Diarrhea

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Nitazoxanide
 Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013