Evaluate the Migration Potential of Xeomin® Compared to Two Other Botulinum Toxin Type A Products
This study has been completed.
Sponsor:
Merz Pharmaceuticals GmbH
Information provided by:
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00515944
First received: August 13, 2007
Last updated: March 31, 2009
Last verified: March 2009
| Tracking Information | |||||
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| First Received Date ICMJE | August 13, 2007 | ||||
| Last Updated Date | March 31, 2009 | ||||
| Start Date ICMJE | August 2007 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Measurement of area | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00515944 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 | Evaluate the Migration Potential of Xeomin® Compared to Two Other Botulinum Toxin Type A Products | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | Xeomin® is a Botulinum neurotoxin type A preparation free of complexing proteins, i.e. free of bacterial proteins other than the active toxin. Injected into the muscle, Xeomin® causes local weakening. Botulinum toxin type A is used for certain neurological and aesthetic treatments. This study will investigate the migration potential of Xeomin®. |
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| Detailed Description | Conducted in Europe |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Drug: Botulinum neurotoxin type A, free of complexing proteins | ||||
| 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 | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Completion Date | June 2008 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00515944 | ||||
| Other Study ID Numbers ICMJE | MRZ 60201-0709/1 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Clinical Pharmacology, Merz Pharmaceuticals | ||||
| Study Sponsor ICMJE | Merz Pharmaceuticals GmbH | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Merz Pharmaceuticals GmbH | ||||
| Verification Date | March 2009 | ||||
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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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