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A Randomized, Double-blind, Placebo-controlled Study on the Efficacy and Safety of CVT-E002 in the Treatment of Upper Respiratory Tract Infections in a Pediatric (3-11 Years) Population

2014-07-23 21:13:32 | BioPortfolio

Summary

Parents with children aged 3-11 will participate in this study. About 400 children will take part in the study. We expect about half of those children will develop symptoms of a respiratory infection. This study will last about 6 months, during which time parents will be instructed to contact study staff if their child has symptoms of a respiratory infection. Those children who do meet the study criteria of symptoms will then be randomly placed (like a flip of a coin) into one of 2 groups to take either liquid COLD-fX® or placebo for 3 days. A placebo will look exactly like liquid COLD-fX® but contains no active ingredients. Your child has an equal chance of being placed in either of the above groups. Neither you nor the study staff will know which study group your child was placed in until the study is completed. If this information is needed in an emergency at any time throughout the study, it is quickly available from the sponsor.

Participation in the study will be for 14 days after symptoms of a respiratory infection are reported to study staff. Your child will take the study product for 3 days, you will complete a daily diary, receive 4 phone calls and be seen for a final study visit to review the diary and complete a final health check of your child.

Description

The primary objective is to assess the efficacy of acute dosing of CVT-E002 in reducing the duration of URTI symptoms in children 3-11 years of age.

The secondary objectives are to asses the efficacy of acute dosing of CVT-E002 in reducing: (1) symptom severity; (2) peak CARIFS scores and; (3) absenteeism for participant and/or parent/guardian. The ease of administration and the safety of acute dosing of CVT-E002 in children 3-11 years of age will also be assessed.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Upper Respiratory Tract Infections

Intervention

North American ginseng, Placebo

Location

Alberta Health Services
Edmonton
Alberta
Canada
T5N 4A3

Status

Recruiting

Source

Afexa Life Sciences Inc

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:13:32-0400

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