Efficacy and Safety Study Of Short Ragweed Pollen Sublingual-Oral Immunotherapy

NCT01353079 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 429

Last updated 2015-02-05

Study results available
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Summary

The primary objective of this study is to demonstrate that SLIT administered pre-and co-seasonally is effective in reducing rhinoconjunctivitis symptoms during the entire short ragweed pollen season.

Conditions

  • Allergy

Interventions

BIOLOGICAL

Short Ragweed Pollen Allergenic Extract

Daily sublingual administration of Short Ragweed Pollen Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.

BIOLOGICAL

Placebo

Placebo: Glycero-COCAs sublingual

Sponsors & Collaborators

  • Greer Laboratories

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-11-30
Completion
2012-04-30

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT01353079 on ClinicalTrials.gov