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Nitazoxanide for the Treatment of Prolonged Diarrhea in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01326338
First Posted: March 30, 2011
Last Update Posted: March 30, 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 was to determine the efficacy of nitazoxanide suspension compared to placebo in treating prolonged diarrhea in children.

Condition Intervention Phase
Diarrhea Drug: Nitazoxanide Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Suspension in the Treatment of Prolonged Diarrhea 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 17 days ]
    Resolution of symptoms defined as resolution of all gastrointestinal symptoms associated with prolonged 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 72 hours to be considered valid.


Enrollment: 100
Study Start Date: March 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nitazoxanide Suspension
Nitazoxanide Oral Suspension 100 mg/5 ml for patients aged 1-3 years or Nitazoxanide Oral Suspension 200 mg/10 ml for patients aged 4-11 years
Drug: Nitazoxanide
Nitazoxanide Oral Suspension 100 mg/5 ml for patients aged 1-3 years twice daily for 3 days or Nitazoxanide Oral Suspension 200 mg/10 ml for patients aged 4-11 years twice daily for 3 days
Other Name: Alinia
Placebo Comparator: Placebo Suspension
Placebo Oral Suspension 5 ml for patients aged 1-3 years and Placebo Oral Suspension 10 ml for patients aged 4-11 years
Drug: Nitazoxanide
Nitazoxanide Oral Suspension 100 mg/5 ml for patients aged 1-3 years twice daily for 3 days or Nitazoxanide Oral Suspension 200 mg/10 ml for patients aged 4-11 years twice daily for 3 days
Other Name: Alinia

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with diarrhea ≥3 days but <30 days duration.
  • No visible blood in stool.

Exclusion Criteria:

  • Use of any antibacterial, antiparasitic or antiviral drugs within 5 days of enrollment.
  • Females who are pregnant, suspected of being pregnant or breastfeeding.
  • Serious systemic disorders incompatible with the study.
  • History of hypersensitivity to nitazoxanide.
  • Patients in whom the possibility of receiving placebo and not being able to receive immediately an effective treatment will be incompatible with the severity of the patient's illness according to the investigator's judgment.
  • Patients known to have or suspected of having AIDS or other immune deficiencies.
  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): NCT01326338


Locations
Peru
Regional Hospital of Cajamarca
Cajamarca, Peru
Sponsors and Collaborators
Romark Laboratories L.C.
Investigators
Principal Investigator: Nicolas Lopez, MD Regional Hospital of Cajamarca
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celine Rossignol, MS, Romark Laboratories, L.C.
ClinicalTrials.gov Identifier: NCT01326338     History of Changes
Other Study ID Numbers: RM02-3019
First Submitted: March 28, 2011
First Posted: March 30, 2011
Last Update Posted: March 30, 2011
Last Verified: March 2011

Keywords provided by Romark Laboratories L.C.:
Diarrhea

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents