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

This study has been completed.
Sponsor:
Information provided by:
Romark Laboratories L.C.
ClinicalTrials.gov Identifier:
NCT01328925
First received: March 29, 2011
Last updated: April 1, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Rotavirus Infection
Viral Gastroenteritis Due to Rotavirus
 Drug: Nitazoxanide
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Romark Laboratories L.C.:

Primary Outcome Measures:
  • Time from first dose to resolution of symptoms. [ Time Frame: Up to 14 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time from first dose to virologic response [ Time Frame: Up to 14 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Frequency of intravenous rehydration required [ Time Frame: Up to 14 days ] [ Designated as safety issue: No ]
  • Stool weight [ Time Frame: Up to 14 days ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: December 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nitazoxanide Oral Suspension
Nitazoxanide Oral Suspension 100 mg/5 ml
 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
Placebo Comparator: Placebo Oral Suspension
Placebo Oral Suspension
 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

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328925

Locations
Egypt
Cairo University Children's Hospital
Cairo, Egypt
Sponsors and Collaborators
Romark Laboratories L.C.
Investigators
Principal Investigator: Mona Abu-Zekry, MD Cairo University Children's Hospital
  More Information

No publications provided

Responsible Party: Celine Rossignol, MS, Romark Laboratories, L.C.
ClinicalTrials.gov Identifier: NCT01328925     History of Changes
Other Study ID Numbers: RM02-3022
Study First Received: March 29, 2011
Last Updated: April 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Romark Laboratories L.C.:
Rotavirus
Viral gastroenteritis
Gastroenteritis

Additional relevant MeSH terms:
Gastroenteritis
Rotavirus Infections
Enteritis
Adenovirus Infections, Human
Enterovirus Infections
Gastrointestinal Diseases
Digestive System Diseases
Reoviridae Infections
RNA Virus Infections
Virus Diseases
 Intestinal Diseases
Adenoviridae Infections
DNA Virus Infections
Picornaviridae Infections
Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013