Nitazoxanide for the Treatment of Prolonged Diarrhea in Children

NCT01326338 | Completed Phase 3

• 1 other identifier: RM02-3019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to determine the efficacy of nitazoxanide suspension compared to placebo in treating prolonged diarrhea in children.

Conditions

Diarrhea

Keywords

Diarrhea

Outcome Measures

Primary Outcomes (1)

• Time from first dose to resolution of symptoms

  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.

  Up to 17 days

Study Arms (2)

Nitazoxanide Suspension

EXPERIMENTAL

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

Placebo Suspension

PLACEBO COMPARATOR

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

Interventions

Nitazoxanide DRUG

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

Also known as: Alinia

Nitazoxanide Suspension; Placebo Suspension

Eligibility Criteria

• Age: 12 Months - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Romark Laboratories L.C.: lead

Study Sites (1)

Regional Hospital of Cajamarca

Cajamarca, Peru

Location

Related Publications (1)

• Rossignol JF, Lopez-Chegne N, Julcamoro LM, Carrion ME, Bardin MC. Nitazoxanide for the empiric treatment of pediatric infectious diarrhea. Trans R Soc Trop Med Hyg. 2012 Mar;106(3):167-73. doi: 10.1016/j.trstmh.2011.11.007. Epub 2012 Jan 31.

  PMID: 22301075 DERIVED

MeSH Terms

Conditions

Diarrhea

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicolas Lopez, MD

  Regional Hospital of Cajamarca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: March 30, 2011
• Study Start: March 1, 2005
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: March 30, 2011

Record last verified: 2011-03

Locations

PE (1)