A Phase III Trial Assessing the Pharmacodynamic Effect and the Tolerability of Grazax Treatment
NCT00773240 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 276
Last updated 2011-08-30
Summary
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
Conditions
- Grass Pollen Allergy
Interventions
- DRUG
-
Grazax
1 tablet, 75,000 SQ-T, daily during the trial period
- DRUG
-
1 placebo tablet, matching the active treatment, daily during the trial period
Sponsors & Collaborators
-
ALK-Abelló A/S
lead INDUSTRY
Principal Investigators
-
Kim Simonsen, MD · ALK-Abelló A/S
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-04-30
- Primary Completion
- 2008-10-31
- Completion
- 2009-02-28
Countries
- Denmark
Study Locations
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