Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children
NCT ID: NCT01328925
Last Updated: 2011-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2005-12-31
2006-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dose Confirmation Efficacy Study (V260-007)
NCT00092443
Reactogenicity, Safety and Immunological Efficacy of the Live, Pentavalent Rotavirus Vaccine in Childhood Immunization
NCT05032391
Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study
NCT02542462
A Study to Evaluate the Safety of Tetravalent Rotavirus Vaccine in Healthy Indian Adult Male Volunteers
NCT01091298
Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)
NCT00130832
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nitazoxanide Oral Suspension
Nitazoxanide Oral Suspension 100 mg/5 ml
Nitazoxanide
Nitazoxanide Oral Suspension dose based on age:
Age \<12 months- 7.5 mg/kg by mouth twice daily for 3 days; Age 12-47 months- 100 mg/5 ml by mouth twice daily for 3 days; Age 48-72 months- 200 mg/10 ml by mouth twice daily for 3 days
Placebo Oral Suspension
Placebo Oral Suspension
Nitazoxanide
Nitazoxanide Oral Suspension dose based on age:
Age \<12 months- 7.5 mg/kg by mouth twice daily for 3 days; Age 12-47 months- 100 mg/5 ml by mouth twice daily for 3 days; Age 48-72 months- 200 mg/10 ml by mouth twice daily for 3 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nitazoxanide
Nitazoxanide Oral Suspension dose based on age:
Age \<12 months- 7.5 mg/kg by mouth twice daily for 3 days; Age 12-47 months- 100 mg/5 ml by mouth twice daily for 3 days; Age 48-72 months- 200 mg/10 ml by mouth twice daily for 3 days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with diarrhea (defined as 3 or more liquid stools per day).
* Stool positive for rotavirus by ELISA.
Exclusion Criteria
* Serious systemic disorders incompatible with the study.
5 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Romark Laboratories L.C.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Romark Laboratories, L.C.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mona Abu-Zekry, MD
Role: PRINCIPAL_INVESTIGATOR
Cairo University Children's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cairo University Children's Hospital
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RM02-3022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.