NCT00965822

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 293 (actual)
• Sponsor: Afexa Life Sciences Inc · Industry
• Sex: All
• Age: 3 Years – 11 Years
• Healthy volunteers: Accepted

Summary

Parents with children aged 3-11 will participate in this study. About 500 children will take part in the study. We expect about half of those children will develop symptoms of a respiratory infection. Active participation in this study will last 14 days after a parent reports symptoms of a respiratory infection in a participant. 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 COLD-FX® or placebo for 3 days. A placebo will look exactly like COLD-FX® but contains no active ingredients. The participant has an equal chance of being placed in either of the above groups. The study is double-blind, so neither the participant nor the study staff will know which study group the participant 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.

Detailed 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.

Conditions

• Upper Respiratory Tract Infections

Interventions

Type	Name	Description
OTHER	North American ginseng	3 day, once daily, dosing
OTHER	Placebo	3 day, once daily dosing

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2009-08-26
• Last updated: 2012-08-31

Locations

4 sites across 1 country: Canada