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Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00250458
First received: November 7, 2005
Last updated: November 5, 2014
Last verified: November 2014
Results First Received: September 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Migraine
Interventions: Drug: Comparator: Rizatriptan
Drug: Comparator: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Twenty-Four (24) investigators in the United States

Primary Therapy Period: MAR06 to OCT06.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Each patient was to treat one migraine attack of moderate or severe intensity with accompanying nausea. Rescue medication was allowed for headache non-response or recurrence after 2 hours postdose. Patients were to treat a qualifying migraine attack within 3 months after randomization.

Reporting Groups
  Description
Rizatriptan 10 mg Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
Placebo Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack

Participant Flow:   Overall Study
    Rizatriptan 10 mg     Placebo  
STARTED     232     114  
COMPLETED     200     97  
NOT COMPLETED     32     17  
Lost to Follow-up                 4                 2  
Protocol Violation                 0                 1  
Withdrawal by Subject                 4                 2  
Lack of Migraine Attack                 20                 9  
Qualifying migraine but did not treat                 3                 3  
Not Specified                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rizatriptan 10 mg Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
Placebo Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
Total Total of all reporting groups

Baseline Measures
    Rizatriptan 10 mg     Placebo     Total  
Number of Participants  
[units: participants]
  232     114     346  
Age  
[units: Years]
Mean ( Full Range )
  40  
  ( 18 to 65 )  
  41  
  ( 18 to 60 )  
  40  
  ( 18 to 65 )  
Gender  
[units: participants]
     
Female     207     103     310  
Male     25     11     36  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Participants With Elimination of Nausea at 2 Hours Postdose   [ Time Frame: At 2 hours after treatment ]

2.  Secondary:   Participants With Pain Relief at 2 Hours Postdose   [ Time Frame: 2 hours after treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


Publications:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00250458     History of Changes
Other Study ID Numbers: 0462-074, 2005_081
Study First Received: November 7, 2005
Results First Received: September 21, 2009
Last Updated: November 5, 2014
Health Authority: United States: Food and Drug Administration