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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

March 28, 2011
March 29, 2011
March 2005
May 2006   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01326338 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Nitazoxanide for the Treatment of Prolonged Diarrhea in Children
Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Suspension in 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diarrhea
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
  • 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
    Intervention: Drug: Nitazoxanide
  • 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
    Intervention: Drug: Nitazoxanide
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. Epub 2012 Jan 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2006
May 2006   (final data collection date for primary outcome measure)

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.
Both
12 Months to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Peru
 
NCT01326338
RM02-3019
No
Celine Rossignol, MS, Romark Laboratories, L.C.
Romark Laboratories L.C.
Not Provided
Principal Investigator: Nicolas Lopez, MD Regional Hospital of Cajamarca
Romark Laboratories L.C.
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP