Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)(COMPLETED)
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00898677
First received: May 8, 2009
Last updated: August 17, 2010
Last verified: August 2010
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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:
Genetics Home Reference related topics:
familial hemiplegic migraine
Drug Information available for:
Potassium benzoate
Sumatriptan
Sumatriptan succinate
Rizatriptan
Rizatriptan benzoate
U.S. FDA Resources
Further study details as provided by Merck:
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:
|
|
Experimental: 2
rizatriptan 10 mg
|
Drug: rizatriptan benzoate
single dose administration of 10 mg rizatriptan p.o.
Other Names:
|
|
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 More Information
Additional Information:
Publications:
| Responsible Party: | Vice President of Late Stage Development, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00898677 History of Changes |
| Other Study ID Numbers: | 2009_591, MK0462-030 |
| Study First Received: | May 8, 2009 |
| Results First Received: | May 21, 2009 |
| Last Updated: | August 17, 2010 |
| 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 Benzoates Sumatriptan Rizatriptan |
Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Vasoconstrictor Agents Cardiovascular Agents 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 May 23, 2013