NCT00366730CompletedPhase 3
Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Entamoeba Histolytica in Children
Romark Laboratories L.C.2 sites in 1 country50 target enrollmentStarted: February 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Romark Laboratories L.C.
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Resolution of clinical symptoms of amebiasis
Study Overview
Brief Summary
The purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by Entamoeba histolytica in children.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 1 Year to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 1 to 11 years.
- •Patients with diarrhea (≥3 bowel movements/day) with one or more enteric symptoms such as bloody stools, rectal bleeding or enlarged colon.
- •Positive stool ELISA test for Entamoeba histolytica within 7 days prior to enrollment.
Exclusion Criteria
- •Patients with identified causes of diarrhea other than E. histolytica.
- •Use within 2 weeks of enrollment of any drug or therapy with possible anti-protozoal activity.
- •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.
- •Patients with amebic liver abscess.
- •Patients known to have or suspected of having AIDS.
- •Patient with immune deficiencies.
Outcomes
Primary Outcomes
Resolution of clinical symptoms of amebiasis
Secondary Outcomes
- Eradication of cyst or trophozoites of E. histolytica from post-treatment stool samples
- Time from initiation of treatment to passage of last unformed stool
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Phase 2
Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in ChildrenNorovirus InfectionRotavirus InfectionAdenoviridae InfectionNCT00302640Romark Laboratories L.C.50
Completed
Phase 3
Study of Nitazoxanide in the Treatment of Amebiasis in Adults and AdolescentsAmebiasisNCT00366236Romark Laboratories L.C.50
Completed
Phase 3
Nitazoxanide for the Treatment of Prolonged Diarrhea in ChildrenDiarrheaNCT01326338Romark Laboratories L.C.100
Completed
Phase 2
Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in ChildrenRotavirus InfectionViral Gastroenteritis Due to RotavirusNCT01328925Romark Laboratories L.C.100
Completed
Phase 3
Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile InfectionPseudomembranous ColitisClostridium EnterocolitisNCT00304356Daniel M. Musher MD22