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
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)
Links
- Source: http://clinicaltrials.gov/show/NCT00965822
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-23T21:13:32-0400
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Medical and Biotech [MESH] Definitions
Cefonicid
A second-generation cephalosporin administered intravenously or intramuscularly. Its bactericidal action results from inhibition of cell wall synthesis. It is used for urinary tract infections, lower respiratory tract infections, and soft tissue and bone infections.
Fusobacterium Nucleatum
A species of gram-negative, anaerobic, rod-shaped bacteria isolated from the gingival margin and sulcus and from infections of the upper respiratory tract and pleural cavity.
Coronavirus Nl63, Human
A species in the genus CORONAVIRUS causing upper and lower RESPIRATORY TRACT INFECTIONS. It shares the receptor used by the SARS VIRUS.
Aphthovirus
A genus of the family PICORNAVIRIDAE infecting mainly cloven-hoofed animals. They cause vesicular lesions and upper respiratory tract infections. FOOT AND MOUTH DISEASE VIRUS is the type species.
Indians, North American
Individual members of North American ethnic groups with ancient historic ancestral origins in Asia.
