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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01328925
First Posted: April 5, 2011
Last Update Posted: April 5, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Romark Laboratories L.C.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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 ]
    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 ]
    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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Celine Rossignol, MS, Romark Laboratories, L.C.
ClinicalTrials.gov Identifier: NCT01328925     History of Changes
Other Study ID Numbers: RM02-3022
First Submitted: March 29, 2011
First Posted: April 5, 2011
Last Update Posted: April 5, 2011
Last Verified: April 2011

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