CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 784 enrolled
Drug / intervention
Ambrosia artemisiifolia allergen extract (Amb a 1-U) +1 morebiological
Likely dose
Ambrosia artemisiifolia allergen extract (Amb a 1-U) 12 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00770315
NCT00770315Phase 3Completed
CompareCT.gov

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adult Subjects With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma

ALK-Abelló A/S·interventional·Posted Oct 10, 2008·Updated Mar 3, 2017

In Brief

A Phase 3 clinical trial evaluating Ambrosia artemisiifolia allergen extract (Amb a 1-U) and Placebo for Rhinitis, Allergic and Conjunctivitis. Completed, enrolled 784 participants.

Detailed Summary

This study will evaluate the efficacy and safety of ragweed sublingual tablet (SCH 39641/MK-3641/Amb a 1-U) compared with placebo in participants with ragweed-induced rhinoconjunctivitis over a one-year period. It is expected that ragweed allergic participants on one of the active arms of the trial will have decreased allergic rhinoconjunctivitis symptoms and require less allergy rescue medications during ragweed pollen season.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRhinitis, Allergic, Conjunctivitis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 10, 2008
Enrollment StartSep 1, 2009
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 17.7 years ago

Interventions

Ambrosia artemisiifolia allergen extract (Amb a 1-U)biological

Rapidly dissolving tablet administered sublingually once daily, at a dose of 1.5, 6 or 12 units.

Placebobiological

Placebo matching Ambrosia artemisiifolia allergen extract rapidly dissolving tablet, administered sublingually once daily