Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch
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ClinicalTrials.gov Identifier: NCT01191359 |
Recruitment Status
:
Completed
First Posted
: August 30, 2010
Last Update Posted
: February 8, 2013
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Sponsor:
ALK-Abelló A/S
Information provided by (Responsible Party):
ALK-Abelló A/S
Tracking Information | ||||
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First Submitted Date ICMJE | August 27, 2010 | |||
First Posted Date ICMJE | August 30, 2010 | |||
Last Update Posted Date | February 8, 2013 | |||
Study Start Date ICMJE | January 2010 | |||
Actual Primary Completion Date | January 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Pharmacodynamic efficacy of two different administration routes of SLITonePLUS Birch [ Time Frame: after 4, 8, 12, 24, 36 weeks of treatment ] specific antibody determination
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Original Primary Outcome Measures ICMJE |
Pharmacodynamic efficacy of two different administration routes of SLITonePLUS Birch | |||
Change History | Complete list of historical versions of study NCT01191359 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Comparison of the two administration routes with regard to safety aspects [ Time Frame: 36 weeks ] adverse events
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Original Secondary Outcome Measures ICMJE |
Comparison of the two administration routes with regard to safety aspects | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch | |||
Official Title ICMJE | A Multicentre Randomised Phase II Clinical Pilot Study to Compare the Pharmacodynamic Efficacy and Tolerability of the Sublingual and the Vestibular Administration Route for SLITonePLUS® Birch | |||
Brief Summary | Multicentre Phase II trial, comparing two different administration routes of SLITonePLUS Birch in regard to pharmacodynamic efficacy and tolerability. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Allergy | |||
Intervention ICMJE | Biological: oral immunotherapy
orally applied specific immunotherapy
Other Name: SLITone birch |
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Study Arms |
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Publications * | Not Provided | |||
* 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 | |||
Actual Enrollment ICMJE |
66 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | January 2011 | |||
Actual Primary Completion Date | January 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Germany | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01191359 | |||
Other Study ID Numbers ICMJE | SP-B-02 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | ALK-Abelló A/S | |||
Study Sponsor ICMJE | ALK-Abelló A/S | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | ALK-Abelló A/S | |||
Verification Date | February 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |