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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00898677
First received: May 8, 2009
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

A study to compare rizatriptan 10 mg verse sumatriptan 100 mg in the treatment of migraine attacks and duration of relief provided. This study will also provide additional efficacy data on rizatriptan 5 mg and 10 mg for the treatment of migraine.


Condition Intervention Phase
Migraine Headache
Drug: rizatriptan benzoate
Drug: Comparator: sumatriptan
Drug: Comparator: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Parallel-Groups, Outpatient Study to Examine the Safety, Tolerability, and Efficacy of Single Oral Doses of MK0462 5 mg, MK0462 10 mg, and Sumatriptan 100 mg for Acute Treatment of Migraine

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Pain Relief at 2 Hours After Dose [ Time Frame: 2 hours after dose ] [ Designated as safety issue: No ]
    Patients 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 Dose [ Time Frame: within 2 hours after dose ] [ Designated as safety issue: No ]
    Patients reporting time to relief defined as the first time point at which a patient reported headache severity grade 1 or 0 (mild pain or no headache) within 2 hours after dose


Secondary Outcome Measures:
  • Pain Free at 2 Hours After Dose [ Time Frame: 2 hours after dose ] [ Designated as safety issue: No ]
    Patients pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each patient rated headache severity on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).

  • Functional Status at 2 Hours After Dose [ Time Frame: 2 hours after dose ] [ Designated as safety issue: No ]
    Patients with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each patient rated functional disability on a 4-grade scale (0 = no functional disability; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 = unable to carry out daily activities, requires bed rest).

  • Nausea at 2 Hours After Dose [ Time Frame: 2 hours after dose ] [ Designated as safety issue: No ]
    Patients who recorded the presence or absence of nausea 2 hours after dose


Enrollment: 1268
Study Start Date: September 1995
Study Completion Date: September 1996
Primary Completion Date: May 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
rizatriptan 5 mg
Drug: rizatriptan benzoate
single dose administration of 5mg rizatriptan (by Mouth) p.o.
Other Names:
  • rizatriptan
  • MK0462
Experimental: 2
rizatriptan 10 mg
Drug: rizatriptan benzoate
single dose administration of 10 mg rizatriptan p.o.
Other Names:
  • rizatriptan
  • MK0462
Active Comparator: 3
sumatriptan 100 mg
Drug: Comparator: sumatriptan
single dose administration of sumatriptan 100 p.o.
Other Name: sumatriptan
Placebo Comparator: 4
placebo
Drug: Comparator: Placebo
placebo to rizatriptan

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient was pregnant or a nursing mother
  • Patient had abused drugs or alcohol within 12 months prior to entering the study
  • Patient had a history of cardiovascular disease
  • Patient had clinically significant Electrocardiography (ECG) abnormality
  • Patient had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
  • Patient received treatment with an investigational device or compound within 30 days of the study start
  • Patient typically suffered from less then 1 or more than 8 attacks of migraine per month
  • Patient had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
  • Patient had hypersensitivity to sumatriptan
  • Patient had participated in any previous study involving rizatriptan
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898677

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00898677     History of Changes
Other Study ID Numbers: 0462-030, 2009_591
Study First Received: May 8, 2009
Results First Received: May 21, 2009
Last Updated: March 7, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Sumatriptan
Rizatriptan
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014