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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Afexa Life Sciences Inc
ClinicalTrials.gov Identifier:
NCT00965822
First received: August 25, 2009
Last updated: August 30, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Upper Respiratory Tract Infections
 Other: North American ginseng
Other: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Common Cold
U.S. FDA Resources

Further study details as provided by Afexa Life Sciences Inc:

Primary Outcome Measures:
  • 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 [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 293
Study Start Date: September 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Other: North American ginseng
3 day, once daily, dosing
Other Name: COLD-FX
Placebo Comparator: 2 Other: Placebo
3 day, once daily dosing

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.

  Eligibility

Ages Eligible for Study:   3 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy individuals of both genders aged years 3 - 11
  2. Willing to adhere to the requirements of the protocol, including availability for follow-up visits
  3. Parent/guardian willing and able to sign written consent

Exclusion Criteria:

  1. Medical conditions:

    • Asthma requiring treatment in the last 3 months with oral steroids - prednisone greater than 10 mg/day
    • Received influenza vaccination for the winter season when the trial is run.
    • Active tuberculosis
    • Cystic fibrosis
    • Significant pulmonary disorders (chronic bronchitis, emphysema or other chronic respiratory illness)
    • Any ongoing allergen immunotherapy during study or for 6 months prior HIV/AIDS
    • Malignancy (under active observation or treatment)
    • Unstable cardiovascular disease (physician visit or hospitalization for unstable cardiovascular disease in the last 6 months)
    • Known renal abnormalities (serum creatinine known to be > upper limit for age group)
    • Acute or active chronic liver disease
    • Diabetes
    • Neurological or psychiatric disease (progressive or currently under treatment)
    • Bleeding disorders
    • Major surgery in the last 6 months or planned surgery over the course of the study
    • Crohn's disease, Juvenile arthritis, Ulcerative Colitis or any other autoimmune disease
    • Other serious medical conditions

  2. Medications:

    • Medications for allergic rhinitis/conjunctivitis, including: antihistamines; oral, parenteral, nasal, and ophthalmic corticosteroids; cromolyn sodium; nedocromil; and intranasal anticholinergics (If the participants agree to stop taking these products prior to study entry and for the duration of the study, they can participate in the study.)
    • Oral or long-acting beta-agonists, theophylline, and leukotriene modifiers
    • Phenelzine
    • Pentobarbital
    • Haloperidol
    • Warfarin
    • Heparin

    • Immunosuppressants

      • Any other natural health products or dietary supplements, with the exception of vitamins and minerals with dose of <600 mg/day of vitamin E and containing no vitamin K. Natural health products or dietary supplements include products such as, but not limited to, Echinacea, Ginseng (beverages, foods, extracts, capsules, or tablets), St. John's Wort, Gingko, Glucosamine, Fish Oil supplements, Evening Primrose Oil, Green Tea or other herbal products consumed in the form of a pill or capsule. (If the participants agree to stop taking these products prior to study entry and for the duration of the study, they can participate in the study.)
  3. Known allergy to any ingredient in the study product or placebo, including: ginseng, icing sugar, stevia leaf powder, mixed berries natural flavour (MC010946), grape natural flavour (MC010947) or caramel color liquid (DN700 caramelan 8-110).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965822

Locations
Canada, Alberta
Alberta Health Services
Edmonton, Alberta, Canada, T5N 4A3
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L4L2
Canada, Nova Scotia
Canadian Center for Vaccinology, Dalhousie University
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
JDM Research
Toronto, Ontario, Canada, M4P 1P2
Sponsors and Collaborators
Afexa Life Sciences Inc
Investigators
Principal Investigator: Shelly McNeil, FRCPC Dalhousie University
  More Information

No publications provided

Responsible Party: Afexa Life Sciences Inc
ClinicalTrials.gov Identifier: NCT00965822     History of Changes
Other Study ID Numbers: CVT-E002-2007-3
Study First Received: August 25, 2009
Last Updated: August 30, 2012
Health Authority: Canada: Health Canada

Keywords provided by Afexa Life Sciences Inc:
URTI
Natural Health Products

Additional relevant MeSH terms:
Respiratory Tract Infections
Common Cold
Infection
Respiratory Tract Diseases
 Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013