Clinical TrialID 927

A Study of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet in Adults With Ragweed Allergies (P05751)

NCT01469182

Allergy

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Record Fields

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Clinical Trial Id
927
Evidence Id
927
Core Evidence Id
927
Source Clinical Trial Id
909
Herb2 Clinical Trial Id
HBCT000909
Nct Id
NCT01469182
Title
A Study of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet in Adults With Ragweed Allergies (P05751)
Status
Completed
Phase
Phase 3
Study Result
Yes
Study Condition
Allergy
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Intervention
BIOLOGICAL: SCH 39641|DRUG: Placebo for SCH 39641
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Double
Intervention Purpose
Treatment
Gender
All
Age
Adult, Older_Adult
Enrollment
914
Outcome Measure
Number of Participants With Treatment-emergent Adverse Events (AEs), Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with treatment-emergent AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization., Up to Day 35
Sponsor Collaborator
ALK-Abelló A/S
Funded By
INDUSTRY
Location
Other Id
P05751|MK-3641
Start Date
2011-11
Primary Completion Date
2012-04
Completion Date
2012-04
First Posted
2011-11-10
Results First Posted
2014-06-05
Last Update Posted
2017-03-03
Study Document
Study Url
https://clinicaltrials.gov/study/NCT01469182
Title Cn
Title En
A Study of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet in Adults With Ragweed Allergies (P05751)
Bilingual Status
semi_complete