NCT00783198

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)

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 565 (actual)
• Sponsor: ALK-Abelló A/S · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of ragweed sublingual tablet (SCH 39641/MK-3641) 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.

Conditions

• Rhinitis; Allergic, With Asthma
• Conjunctivitis

Interventions

Type	Name	Description
BIOLOGICAL	SCH 39641 6 Amb a 1-U	SCH 39641 6 Amb a 1-U sublingual tablets administered once daily
BIOLOGICAL	SCH 39641 12 Amb a 1-U	SCH 39641 12 Amb a 1-U sublingual tablets administered once daily
BIOLOGICAL	Placebo	matching placebo sublingual tablets administered once daily

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2008-10-31
• Last updated: 2017-03-03
• Results posted: 2014-07-14