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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 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 784

Last updated 2017-03-03

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Ambrosia artemisiifolia allergen extract (Amb a 1-U)

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

BIOLOGICAL

Placebo

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

Sponsors & Collaborators

  • ALK-Abelló A/S

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-05-31
Completion
2011-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00770315 on ClinicalTrials.gov