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Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00898677
First Posted: May 12, 2009
Last Update Posted: March 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: May 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Migraine Headache
Interventions: Drug: rizatriptan benzoate
Drug: Comparator: sumatriptan
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

Patients were recruited at 47 sites in 21 countries in Canada, South America, Europe, Middle East, South Africa, and Australia

First Patient Treated: September 1995

Last Patient Treated: May 1996


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Outpatients screened at a pretreatment visit were given allocated drug supply with instructions. If patients had not treated an attack within 2 months of being enrolled, they were required to return for a rescreen visit. If by 4 months after being enrolled patients still had not treated an attack, they were discontinued from the study.

Reporting Groups
  Description
Rizatriptan 5 mg Rizatriptan 5 mg orally once for treatment of single migraine attack
Rizatriptan 10 mg Rizatriptan 10 mg orally once for treatment of single migraine attack
Sumatriptan 100 mg Sumatriptan 100 mg orally once for treatment of single migraine attack
Placebo Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack

Participant Flow:   Overall Study
    Rizatriptan 5 mg   Rizatriptan 10 mg   Sumatriptan 100 mg   Placebo
STARTED   180   455   455   178 
Patients Treated   164 [1]   387 [2]   388 [3]   160 [4] 
COMPLETED   163   386   383   159 
NOT COMPLETED   17   69   72   19 
Adverse Event                0                0                1                0 
Lost to Follow-up                0                0                2                0 
Protocol Violation                1                1                2                0 
Withdrawal by Subject                0                0                0                1 
Not Treated: Adverse Event                0                2                1                0 
Not Treated: Lost to Follow-Up                0                5                5                2 
Not Treated: Pregnancy                0                0                1                0 
Not Treated: Protocol Violation                2                0                2                0 
Not Treated: Withdraw by Subject                2                16                11                3 
Not Treated: Patient uncooperative                2                3                1                0 
Not Treated: Abnormal Prestudy Labs                0                0                0                1 
Not Treated: Abnormal Baseline ECG                1                0                0                0 
Not Treated: No Longer Met Inc Criteria                0                3                1                0 
Not Treated: Lack of Migraine Attack                9                39                43                12 
Not Treated: Other (Not Specified)                0                0                2                0 
[1] Patients Not Treated: 16
[2] Patients Not Treated: 68
[3] Patients Not Treated: 67
[4] Patients Not Treated: 18



  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 5 mg

Rizatriptan 5 mg orally once for treatment of single migraine attack.

Baseline measure Participants reported are those participants that recieved study treatment.

Rizatriptan 10 mg

Rizatriptan 10 mg orally once for treatment of single migraine attack

Baseline measure Participants reported are those participants that recieved study treatment.

Sumatriptan 100 mg

Sumatriptan 100 mg orally once for treatment of single migraine attack

Baseline measure Participants reported are those participants that recieved study treatment.

Placebo

Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack

Baseline measure Participants reported are those participants that recieved study treatment.

Total Total of all reporting groups

Baseline Measures
   Rizatriptan 5 mg   Rizatriptan 10 mg   Sumatriptan 100 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 164   387   388   160   1099 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.3  (10.3)   37.0  (10.0)   39.2  (10.1)   38.3  (10.3)   38.2  (10.2) 
Gender 
[Units: Participants]
         
Female   138   319   309   132   898 
Male   26   68   79   28   201 
Baseline Headache Severity [1] 
[Units: Participants]
         
Grades 1, 0: Mild, no pain, or missing   0   0   1   1   2 
Grade 2: Moderate   72   174   191   75   512 
Grade 3: Severe   92   213   196   84   585 
[1] Each patient rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).
Race/Ethnicity 
[Units: Participants]
         
Caucasian   117   282   281   120   800 
Black   1   5   3   0   9 
Asian   0   1   2   0   3 
Hispanic   33   80   77   32   222 
Mestizo   9   15   22   7   53 
Mexican   0   2   2   0   4 
Colored   0   0   1   0   1 
Mexican/Hispanic   1   0   0   0   1 
Mixed   2   2   0   1   5 
Asian/Caucasian   1   0   0   0   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pain Relief at 2 Hours After Dose   [ Time Frame: 2 hours after dose ]

2.  Primary:   Time to Relief Within 2 Hours After Dose   [ Time Frame: within 2 hours after dose ]

3.  Secondary:   Pain Free at 2 Hours After Dose   [ Time Frame: 2 hours after dose ]

4.  Secondary:   Functional Status at 2 Hours After Dose   [ Time Frame: 2 hours after dose ]

5.  Secondary:   Nausea at 2 Hours After Dose   [ Time Frame: 2 hours after dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:
Other Publications:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00898677     History of Changes
Other Study ID Numbers: 0462-030
2009_591
First Submitted: May 8, 2009
First Posted: May 12, 2009
Results First Submitted: May 21, 2009
Results First Posted: July 14, 2009
Last Update Posted: March 4, 2015