A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Using Alcohol Wipes Prior to Daily Injections of Copaxone®.
This study has been completed.
Sponsor:
Teva Neuroscience, Inc.
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00220922
First received: September 20, 2005
Last updated: April 7, 2011
Last verified: April 2011
| Tracking Information | |||||
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| First Received Date ICMJE | September 20, 2005 | ||||
| Last Updated Date | April 7, 2011 | ||||
| Start Date ICMJE | August 2004 | ||||
| Primary Completion Date | October 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Total number of local injection site reactions (LISRs) noted at 5-minutes post-injection [ Time Frame: four weeks of Period 1 and the four weeks of Period 2 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00220922 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
The total number of LISRs noted at 2-minutes post-injection The total number of LISRs noted immediately after injection [ Time Frame: four weeks of Period 1 and the four weeks of Period 2 ] [ Designated as safety issue: No ] | ||||
| 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 | A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Using Alcohol Wipes Prior to Daily Injections of Copaxone®. | ||||
| Official Title ICMJE | An Open-Label, Randomized, Single Cross-Over Study of Isopropyl Alcohol Wipes Versus No Injection Site Preparation on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone® | ||||
| Brief Summary | This study is designed to compare injection site reactions with or without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Multiple Sclerosis | ||||
| Intervention ICMJE | Procedure: Alcohol Wipes vs. No Alcohol Wipes
Other Name: Copaxone |
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| Study Arm (s) |
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| 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 | 50 | ||||
| Completion Date | February 2006 | ||||
| Primary Completion Date | October 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 and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00220922 | ||||
| Other Study ID Numbers ICMJE | PM013 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Thomas Smith, M.D., Vice President, Medical Affairs, Teva Neuroscience | ||||
| Study Sponsor ICMJE | Teva Neuroscience, Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Teva Pharmaceutical Industries | ||||
| Verification Date | April 2011 | ||||
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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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