Back to resultsNitazoxanide for the Treatment of Prolonged Diarrhea in Children
Primary Purpose
Diarrhea
Status
Completed
Phase
Phase 3
Locations
Peru
Study Type
Interventional
Intervention
Nitazoxanide
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhea focused on measuring Diarrhea
Eligibility 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.
Sites / Locations
- Regional Hospital of Cajamarca
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nitazoxanide Suspension
Placebo Suspension
Arm Description
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
Placebo Oral Suspension 5 ml for patients aged 1-3 years and Placebo Oral Suspension 10 ml for patients aged 4-11 years
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01326338
First Posted
March 28, 2011
Last Updated
March 29, 2011
Sponsor
Romark Laboratories L.C.
1. Study Identification
Unique Protocol Identification Number
NCT01326338
Brief Title
Nitazoxanide for the Treatment of Prolonged Diarrhea in Children
Official Title
Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Suspension in the Treatment of Prolonged Diarrhea in Children
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Romark Laboratories L.C.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to determine the efficacy of nitazoxanide suspension compared to placebo in treating prolonged diarrhea in children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
Keywords
Diarrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nitazoxanide Suspension
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo Suspension
Arm Type
Placebo Comparator
Arm Description
Placebo Oral Suspension 5 ml for patients aged 1-3 years and Placebo Oral Suspension 10 ml for patients aged 4-11 years
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide
Other Intervention Name(s)
Alinia
Intervention Description
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
Primary Outcome Measure Information:
Title
Time from first dose to resolution of symptoms
Description
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.
Time Frame
Up to 17 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Lopez, MD
Organizational Affiliation
Regional Hospital of Cajamarca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional Hospital of Cajamarca
City
Cajamarca
Country
Peru
12. IPD Sharing Statement
Citations:
PubMed Identifier
22301075
Citation
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.
Results Reference
derived
Learn more about this trial
Nitazoxanide for the Treatment of Prolonged Diarrhea in Children
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