Clinical TrialID 813
Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adults With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (Study P05234)
NCT00770315
Rhinitis, Allergic|Conjunctivitis
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Record Fields
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- Clinical Trial Id
- 813
- Evidence Id
- 813
- Core Evidence Id
- 813
- Source Clinical Trial Id
- 795
- Herb2 Clinical Trial Id
- HBCT000795
- Nct Id
- NCT00770315
- Title
- Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adults With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (Study P05234)
- Status
- Completed
- Phase
- Phase 2|Phase 3
- Study Result
- Yes
- Study Condition
- Rhinitis, Allergic|Conjunctivitis
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
- Intervention
- BIOLOGICAL: Ambrosia artemisiifolia allergen extract (Amb a 1-U)|BIOLOGICAL: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Double
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult
- Enrollment
- 784
- Outcome Measure
- Combined (Sum of) Rhinoconjunctivitis Daily Symptom Score (DSS) and Daily Medication Score (DMS) Averaged Over the Peak Ragweed Season (RS), The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Rhinoconjunctivitis DMS was based on use of specific study-provided rescue medication, with different rescue medications being assigned different scores/dose unit (score range: 0-36), with a lower score indicating less rhinconjunctivitis medication use. The sum of the rhinoconjunctivitis DSS+DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects., The 15-day period during the ragweed season with the highest moving pollen average
- Sponsor Collaborator
- ALK-Abelló A/S
- Funded By
- INDUSTRY
- Location
- Other Id
- P05234|3810249|2008-003864-20|MK-3641-002
- Start Date
- 2009-09
- Primary Completion Date
- 2011-05
- Completion Date
- 2011-05
- First Posted
- 2008-10-10
- Results First Posted
- 2014-07-03
- Last Update Posted
- 2017-03-03
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT00770315
- Title Cn
- Title En
- Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adults With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (Study P05234)
- Bilingual Status
- semi_complete