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Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children

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ClinicalTrials.gov Identifier: NCT01328925
Recruitment Status : Completed
First Posted : April 5, 2011
Last Update Posted : April 5, 2011
Sponsor:
Information provided by:
Romark Laboratories L.C.

March 29, 2011
April 5, 2011
April 5, 2011
December 2005
June 2006   (Final data collection date for primary outcome measure)
Time from first dose to resolution of symptoms. [ Time Frame: Up to 14 days ]
Resolution of all gastrointestinal symptoms associated with viral 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 48 hours to be considered valid.
Same as current
No Changes Posted
  • Time from first dose to virologic response [ Time Frame: Up to 14 days ]
    Daily stool samples will be analyzed by ELISA for the presence of rotavirus. Virologic response is defined by a negative ELISA stool test for rotavirus on 2 consecutive days.
  • Time from first dose to hospital discharge [ Time Frame: Up to 14 days ]
    For hospitalized patients, the study will monitor the time in hours from the first dose of study medication to discharge from the hospital.
  • Volume of oral rehydration solutions consumed [ Time Frame: Up to 14 days ]
  • Frequency of intravenous rehydration required [ Time Frame: Up to 14 days ]
  • Stool weight [ Time Frame: Up to 14 days ]
Same as current
Not Provided
Not Provided
 
Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children
Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children
The purpose of this study is to determine the effectiveness of nitazoxanide suspension compared to placebo in treating rotavirus disease in pediatric patients less than 6 years of age.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Rotavirus Infection
  • Viral Gastroenteritis Due to Rotavirus
Drug: 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 Names:
  • Alinia
  • NTZ
  • Experimental: Nitazoxanide Oral Suspension
    Nitazoxanide Oral Suspension 100 mg/5 ml
    Intervention: Drug: Nitazoxanide
  • Placebo Comparator: Placebo Oral Suspension
    Placebo Oral Suspension
    Intervention: Drug: Nitazoxanide
Not Provided

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

Inclusion Criteria:

  • Age < 6 years.
  • Patients with diarrhea (defined as 3 or more liquid stools per day).
  • Stool positive for rotavirus by ELISA.

Exclusion Criteria:

  • Other identified causes of diarrhea at screening (pathogenic protozoa, bacteria, viruses or lactose intolerance).
  • Serious systemic disorders incompatible with the study.
Sexes Eligible for Study: All
up to 5 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
 
NCT01328925
RM02-3022
No
Not Provided
Not Provided
Celine Rossignol, MS, Romark Laboratories, L.C.
Romark Laboratories L.C.
Not Provided
Principal Investigator: Mona Abu-Zekry, MD Cairo University Children's Hospital
Romark Laboratories L.C.
April 2011

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