A Phase III Trial Assessing the Pharmacodynamic Effect and the Tolerability of Grazax Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-02-28

Brief Summary

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The study assess the pharmacodynamic effect and the tolerability of Grazax treatment initiated in the grass pollen season in subjects with seasonal grass pollen induced rhinoconjunctivitis

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Detailed Description

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Conditions

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Grass Pollen Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Grazax

Group Type EXPERIMENTAL

Grazax

Intervention Type DRUG

1 tablet, 75,000 SQ-T, daily during the trial period

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

1 placebo tablet, matching the active treatment, daily during the trial period

Interventions

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Grazax

1 tablet, 75,000 SQ-T, daily during the trial period

Intervention Type DRUG

placebo

1 placebo tablet, matching the active treatment, daily during the trial period

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Positive skin prick test to Phleum pratense
* Positive IgE to Phleum pratense
* signed informed consent
* A clinical history of moderate to severe persistent rhinoconjunctivitis symptoms

Exclusion Criteria

* No uncontrolled asthma in the past 12 months
* No history of an IgE mediated systemic reaction due to food, insect venom, any kind of medication or induced by exercise, where there are symptoms both from the skin and the respiratory system with or without hypotension
* No history of an IgE mediated systemic reaction due to food, insect venom, any kind of medication or induced by exercise, where there are symptoms both from the skin and the respiratory system with or without hypotension

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No