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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 9, 2005 | ||||
| Last Updated Date | July 16, 2008 | ||||
| Start Date ICMJE | March 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00263952 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy and Safety of a Purified Standardised Bee Venom Preparation | ||||
| Official Title ICMJE | Immunotherapy of Bee Venom Allergy: Evaluation of a New Purified Bee Venom Preparation in Comparison With Already Published Studies. | ||||
| Brief Summary | The trial is performed to assess efficacy and safety of a purified standardised bee venom preparation in bee venom allergy |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Bee Venom Allergy | ||||
| Intervention ICMJE | Biological: bee venom | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | April 2010 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00263952 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | Al0202ig | ||||
| Study Sponsor ICMJE | Allergopharma Joachim Ganzer KG | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Allergopharma Joachim Ganzer KG | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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