Assessment of Grazax® Treatment Compliance
This study has been completed.
Sponsor:
ALK-Abelló A/S
Information provided by:
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT00293046
First received: February 16, 2006
Last updated: September 29, 2008
Last verified: September 2008
| Tracking Information | |||||
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| First Received Date ICMJE | February 16, 2006 | ||||
| Last Updated Date | September 29, 2008 | ||||
| Start Date ICMJE | February 2006 | ||||
| Primary Completion Date | September 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Assessment of treatment compliance by recording of drug accountability | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00293046 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Recording of adverse events | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Assessment of Grazax® Treatment Compliance | ||||
| Official Title ICMJE | A Randomised, Parallel-Group, Open, Controlled Phase III Trial Assessing the Treatment Compliance With GRAZAX® in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis | ||||
| Brief Summary | This trial is performed to assess whether the Grazax® treatment compliance can be improved by use of a compliance device (Memozax®). |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
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| Condition ICMJE | Allergy | ||||
| Intervention ICMJE | Biological: ALK Grass tablet - use of compliance device | ||||
| 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 | 500 | ||||
| Completion Date | October 2007 | ||||
| Primary Completion Date | September 2006 (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 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Austria | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00293046 | ||||
| Other Study ID Numbers ICMJE | GT-10 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | ALK-Abelló A/S | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | ALK-Abelló A/S | ||||
| Verification Date | September 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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