MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)(COMPLETED)
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00897104
First received: May 8, 2009
Last updated: June 9, 2011
Last verified: June 2011
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| Tracking Information | |||||
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| First Received Date ICMJE | May 8, 2009 | ||||
| Last Updated Date | June 9, 2011 | ||||
| Start Date ICMJE | August 1995 | ||||
| Primary Completion Date | May 1996 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00897104 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)(COMPLETED) | ||||
| Official Title ICMJE | A Randomized, Placebo-Controlled, Parallel-Groups, Outpatient Study to Compare the Efficacy and Safety of MK0462 5 mg p.o. and Sumatriptan 50 mg p.o. for the Acute Treatment of Migraine | ||||
| Brief Summary | A study to compare rizatriptan (MK0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for the acute treatment of a migraine attack. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Migraine Headache | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Ho TW, Fan X, Rodgers A, Lines CR, Winner P, Shapiro R. Age effects on placebo response rates in clinical trials of acute agents for migraine: pooled analysis of rizatriptan trials in adults. Cephalalgia. 2009 Feb 3; [Epub ahead of print] | ||||
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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 | 933 | ||||
| Completion Date | September 1996 | ||||
| Primary Completion Date | May 1996 (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 | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00897104 | ||||
| Other Study ID Numbers ICMJE | MK-0462-029, 2009_593 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp | ||||
| Study Sponsor ICMJE | Merck | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Merck | ||||
| Verification Date | June 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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