Status:
COMPLETED
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
Lead Sponsor:
Afexa Life Sciences Inc
Conditions:
Upper Respiratory Tract Infections
Eligibility:
All Genders
3-11 years
Phase:
PHASE2
Brief 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....
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...
Eligibility Criteria
Inclusion
- Healthy individuals of both genders aged years 3 - 11
- Willing to adhere to the requirements of the protocol, including availability for follow-up visits
- Parent/guardian willing and able to sign written consent
Exclusion
- 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
- 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.)
- 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).
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
293 Patients enrolled
Trial Details
Trial ID
NCT00965822
Start Date
September 1 2009
End Date
April 1 2012
Last Update
August 31 2012
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Alberta Health Services
Edmonton, Alberta, Canada, T5N 4A3
2
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L4L2
3
Canadian Center for Vaccinology, Dalhousie University
Halifax, Nova Scotia, Canada, B3K 6R8
4
JDM Research
Toronto, Ontario, Canada, M4P 1P2