Safety and Efficacy of House Dust Mite Allergen Extract in the Treatment of Allergic Rhinoconjunctivitis
This study has been completed.
Sponsor:
Allergopharma GmbH & Co. KG
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00263549
First received: December 8, 2005
Last updated: February 8, 2013
Last verified: February 2013
| Tracking Information | |||||
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| First Received Date ICMJE | December 8, 2005 | ||||
| Last Updated Date | February 8, 2013 | ||||
| Start Date ICMJE | September 2002 | ||||
| Primary Completion Date | February 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00263549 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety and Efficacy of House Dust Mite Allergen Extract in the Treatment of Allergic Rhinoconjunctivitis | ||||
| Official Title ICMJE | Multicenter Study for Evaluation of Efficacy and Safety of Perennial Specific Immunotherapy With a Depot House Dust Mite Allergen Extract (D. Pteronyssinus 100%) in Patients With House Dust Mite Sensitivity | ||||
| Brief Summary | The trial is performed to assess efficacy and safety of Novo-Helisen Depot in allergic Rhinoconjunctivitis |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | House Dust Mite Allergy | ||||
| Intervention ICMJE | Biological: House dust mite Novo Helisen Depot | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | February 2006 | ||||
| Primary Completion Date | February 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 55 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 Number ICMJE | NCT00263549 | ||||
| Other Study ID Numbers ICMJE | Al0201NH | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Allergopharma GmbH & Co. KG | ||||
| Study Sponsor ICMJE | Allergopharma GmbH & Co. KG | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Allergopharma GmbH & Co. KG | ||||
| Verification Date | February 2013 | ||||
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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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