MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00897104
First received: May 8, 2009
Last updated: March 7, 2014
Last verified: March 2014

May 8, 2009
March 7, 2014
August 1995
May 1996   (final data collection date for primary outcome measure)
  • Pain Relief at 2 Hours After Treatment [ Time Frame: 2 hours after treatment ] [ Designated as safety issue: No ]
    Participants reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment
  • Time to Relief Within 2 Hours After Treatment [ Time Frame: within 2 hours after treatment ] [ Designated as safety issue: No ]
    Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg).
  • Pain relief at 2 hours after treatment [ Time Frame: 2 hours after treatment ] [ Designated as safety issue: No ]
  • Time to relief within 2 hours after treatment [ Time Frame: within 2 hours after treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00897104 on ClinicalTrials.gov Archive Site
  • Pain Free at 2 Hours After Treatment [ Time Frame: 2 hours after treatment ] [ Designated as safety issue: No ]
    Participants pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).
  • Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities [ Time Frame: 2 hours after treatment ] [ Designated as safety issue: No ]
    Participants with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each participant rated functional disability on a 4-grade scale (0 =normal; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 =unable to carry out daily activities, required bed rest).
  • Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment [ Time Frame: 2 hours after treatment ] [ Designated as safety issue: No ]
    Participants who recorded the presence or absence of the associated symptoms photophobia, phonophobia, nausea, and vomiting at 2 hours after treatment.
  • Participants Who Used Escape Medication 2 Hours After the Treatment Dose [ Time Frame: 2 hours after treatment ] [ Designated as safety issue: No ]
    Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication.
  • Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1]) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Duration of relief or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1) was calculated for responders who had a headache recurrence
  • Pain free at 2 hours after treatment [ Time Frame: 2 hours after treatment ] [ Designated as safety issue: No ]
  • No functional disability at 2 hours after treatment [ Time Frame: 2 hours after treatment ] [ Designated as safety issue: No ]
  • Presence or absence of associated symptoms (photophobia, phonophobia, nausea, and vomiting) at 2 hours after treatment [ Time Frame: 2 hours after treatment ] [ Designated as safety issue: No ]
  • Patients who used escape medication 2 hours after the treatment dose [ Time Frame: 2 hours after treatment ] [ Designated as safety issue: No ]
  • Duration of relief (Time to recurrence from the time of first recorded pain relief [grade = 0 or 1]) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Migraine Headache
  • Drug: rizatriptan benzoate (MK0462)
    single dose 5 mg rizatriptan p.o.
    Other Name: MK0462
  • Drug: Comparator: sumatriptan
    single dose 50 mg sumatriptan p.o.
  • Drug: Comparator: Placebo
    Placebo to rizatriptan or sumatriptan, single dose placebo tablet taken orally
  • Experimental: 1
    Rizatriptan
    Intervention: Drug: rizatriptan benzoate (MK0462)
  • Experimental: 2
    Sumatriptan
    Intervention: Drug: Comparator: sumatriptan
  • Placebo Comparator: 3
    Placebo
    Intervention: Drug: Comparator: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
933
September 1996
May 1996   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participant had at least a 6-month history of migraine, with or without aura
  • Participant was male, or if female, must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions
  • Participant was judged to be in good health, apart from migraine

Exclusion Criteria:

  • Participant was Pregnant or a nursing mother
  • Participant had a history or current evidence of drug or alcohol abuse
  • Participant had a history or clinical evidence of cardiovascular disease
  • Participant had a clinically significant Electrocardiography (ECG) abnormality
  • Participant had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
  • Participant had received treatment with an investigational device or compound within 30 days of the study
  • Participant typically suffered from less then 1 or more than 8 attacks of migraine per month
  • Participant had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
  • Participant was currently taking monoamine oxidase inhibitors, methysergide or lithium
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00897104
0462-029, 2009_593
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP