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

Rotavirus Infection Clinical Trial

Official title:

Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01328925
• Other study ID #: RM02-3022
• Status: Completed
• Phase: Phase 2
• First received: March 29, 2011
• Last updated: April 1, 2011
• Start date: December 2005
• Est. completion date: June 2006

Study information

• Verified date: April 2011
• Source: Romark Laboratories L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenovirus Infections, Human
• Enteritis
• Enterovirus Infections
• Gastroenteritis
• Rotavirus Infection
• Rotavirus Infections
• Viral Gastroenteritis Due to Rotavirus

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo University Children's Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Romark Laboratories L.C.

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from first dose to resolution of symptoms.	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.	Up to 14 days	No
Secondary	Time from first dose to virologic response	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.	Up to 14 days	No
Secondary	Time from first dose to hospital discharge	For hospitalized patients, the study will monitor the time in hours from the first dose of study medication to discharge from the hospital.	Up to 14 days	No
Secondary	Volume of oral rehydration solutions consumed		Up to 14 days	No
Secondary	Frequency of intravenous rehydration required		Up to 14 days	No
Secondary	Stool weight		Up to 14 days	No