Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen
NCT ID: NCT01012531
Last Updated: 2011-07-14
Study Results
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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COMPLETED
PHASE3
121 participants
INTERVENTIONAL
2008-10-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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highly polymerized allergen extract
Subcutaneous injections with highly polymerized allergen extract
cluster schedule
Placebo
Subcutaneous injection with placebo
cluster schedule
Interventions
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Subcutaneous injections with highly polymerized allergen extract
cluster schedule
Subcutaneous injection with placebo
cluster schedule
Eligibility Criteria
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Inclusion Criteria
* Positive screening skin prick test (wheal diameter \> 3 mm)
* Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
* Signed and dated patient´s Informed Consent,
Exclusion Criteria
* Simultaneous participation in other clinical trials,
* Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
* Auto-immune disorders,
* Severe chronic inflammatory diseases,
* Malignancy,
* Alcohol abuse,
* Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
* Patients being in any relationship or dependency with the sponsor and/or investigator,
* Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
18 Years
75 Years
ALL
No
Sponsors
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Roxall Medizin
INDUSTRY
Responsible Party
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Roxall Medizin
Locations
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Zentrum für Rhinologie und Allergologie
Wiesbaden, , Germany
Countries
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Other Identifiers
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CLU-2008-001
Identifier Type: -
Identifier Source: org_study_id
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