Clinical TrialID 928
Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet in Adults With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (Study P05233)(COMPLETED)
NCT00783198
Rhinitis; Allergic, With Asthma|Conjunctivitis
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 928
- Evidence Id
- 928
- Core Evidence Id
- 928
- Source Clinical Trial Id
- 910
- Herb2 Clinical Trial Id
- HBCT000910
- Nct Id
- NCT00783198
- Title
- Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet in Adults With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (Study P05233)(COMPLETED)
- Status
- Completed
- Phase
- Phase 2|Phase 3
- Study Result
- Yes
- Study Condition
- Rhinitis; Allergic, With Asthma|Conjunctivitis
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
- Intervention
- BIOLOGICAL: SCH 39641 6 Amb a 1-U|BIOLOGICAL: SCH 39641 12 Amb a 1-U|BIOLOGICAL: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Double
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult
- Enrollment
- 565
- 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). Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36. The sum of the rhinoconjunctivitis DSS and DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means for DSS+DMS were converted to adjusted means based on an analysis of variance (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
- P05233|2008-003863-38|MK-3641-002
- Start Date
- 2009-09
- Primary Completion Date
- 2011-05
- Completion Date
- 2011-05
- First Posted
- 2008-10-31
- Results First Posted
- 2014-07-14
- Last Update Posted
- 2017-03-03
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT00783198
- Title Cn
- Title En
- Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet in Adults With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (Study P05233)(COMPLETED)
- Bilingual Status
- semi_complete