Clinical TrialID 8553

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

NCT00965822

Upper Respiratory Tract Infections

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Record Fields

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Clinical Trial Id
8553
Evidence Id
8553
Core Evidence Id
8553
Source Clinical Trial Id
8553
Herb2 Clinical Trial Id
HBCT008553
Nct Id
NCT00965822
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
Status
Completed
Phase
Phase 2
Study Result
No
Study Condition
Upper Respiratory Tract Infections
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Intervention
OTHER: North American ginseng|OTHER: Placebo
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Quadruple
Intervention Purpose
Treatment
Gender
All
Age
Child
Enrollment
293
Outcome Measure
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, 14 days
Sponsor Collaborator
Afexa Life Sciences Inc
Funded By
INDUSTRY
Location
Alberta Health Services, Edmonton, Alberta, T5N 4A3, Canada|Saint John Regional Hospital, Saint John, New Brunswick, E2L4L2, Canada|Canadian Center for Vaccinology, Dalhousie University, Halifax, Nova Scotia, B3K 6R8, Canada|JDM Research, Toronto, Ontario, M4P 1P2, Canada
Other Id
CVT-E002-2007-3
Start Date
2009-09-01 00:00:00
Primary Completion Date
2012-04-01 00:00:00
Completion Date
2012-04-01 00:00:00
First Posted
2009-08-26 00:00:00
Results First Posted
Last Update Posted
2012-08-31 00:00:00
Study Document
Study Url
https://clinicaltrials.gov/study/NCT00965822
Title Cn
Title En
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
Bilingual Status
semi_complete