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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_591 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | rizatriptan 5 mg |
|
| 2 | Experimental | rizatriptan 10 mg |
|
| 3 | Active Comparator | sumatriptan 100 mg |
|
| 4 | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rizatriptan benzoate | Drug | single dose administration of 5mg rizatriptan (by Mouth) p.o. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief at 2 Hours After Dose | 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 | 2 hours after dose |
| Time to Relief Within 2 Hours After Dose | 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 | within 2 hours after dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Free at 2 Hours After Dose | 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). | 2 hours after dose |
| Functional Status at 2 Hours After Dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19222588 | Background | Ho TW, Rodgers A, Bigal ME. Impact of recent prior opioid use on rizatriptan efficacy. A post hoc pooled analysis. Headache. 2009 Mar;49(3):395-403. doi: 10.1111/j.1526-4610.2009.01346.x. Epub 2008 Feb 12. | |
| 11284463 | Result | Tfelt-Hansen P, Teall J, Rodriguez F, Giacovazzo M, Paz J, Malbecq W, Block GA, Reines SA, Visser WH. Oral rizatriptan versus oral sumatriptan: a direct comparative study in the acute treatment of migraine. Rizatriptan 030 Study Group. Headache. 1998 Nov-Dec;38(10):748-55. doi: 10.1046/j.1526-4610.1998.3810748.x. |
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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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Rizatriptan 5 mg | Rizatriptan 5 mg orally once for treatment of single migraine attack |
| FG001 | Rizatriptan 10 mg | Rizatriptan 10 mg orally once for treatment of single migraine attack |
| FG002 | Sumatriptan 100 mg | Sumatriptan 100 mg orally once for treatment of single migraine attack |
| FG003 | Placebo | Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Rizatriptan 10 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Relief at 2 Hours After Dose | 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 | An "all-patients-treated" approach was used in the primary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication. Missing values in the treatment phase (i.e., after the baseline phase) were imputed by carrying forward the preceding values in the same phase. | Posted | Number | Participants | 2 hours after dose |
|
During the 24 hours treatment period, and up to and including 7 days after the last dose of study therapy.
Although a patient may have had two or more adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
Adverse Event participants reported are those participants that received study treatment and had safety follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rizatriptan 5 mg | Rizatriptan 5 mg orally once for treatment of single migraine attack |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endometriosis | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia/Fatigue | General disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C093622 | rizatriptan |
| D018170 | Sumatriptan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| rizatriptan benzoate | Drug | single dose administration of 10 mg rizatriptan p.o. |
|
|
| Comparator: sumatriptan | Drug | single dose administration of sumatriptan 100 p.o. |
|
|
| Comparator: Placebo | Drug | placebo to rizatriptan |
|
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). |
| 2 hours after dose |
| Nausea at 2 Hours After Dose | Patients who recorded the presence or absence of nausea 2 hours after dose | 2 hours after dose |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Not Treated: Adverse Event |
|
| Not Treated: Lost to Follow-Up |
|
| Not Treated: Pregnancy |
|
| Not Treated: Protocol Violation |
|
| Not Treated: Withdraw by Subject |
|
| Not Treated: Patient uncooperative |
|
| Not Treated: Abnormal Prestudy Labs |
|
| Not Treated: Abnormal Baseline ECG |
|
| Not Treated: No Longer Met Inc Criteria |
|
| Not Treated: Lack of Migraine Attack |
|
| Not Treated: Other (Not Specified) |
|
Rizatriptan 10 mg orally once for treatment of single migraine attack
Baseline measure Participants reported are those participants that recieved study treatment.
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Baseline Headache Severity | Each patient rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain). | Number | participants |
|
| Race/Ethnicity | Number | participants |
|
Rizatriptan 10 mg orally once for treatment of single migraine attack |
| OG002 | Sumatriptan 100 mg | Sumatriptan 100 mg orally once for treatment of single migraine attack |
| OG003 | Placebo | Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack |
|
|
| Primary | Time to Relief Within 2 Hours After Dose | 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 | An "all-patients-treated" approach was used in the primary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication. | Posted | Number | Participants | within 2 hours after dose |
|
|
|
| Secondary | Pain Free at 2 Hours After Dose | 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). | An "all-patients-treated" approach was used in the secondary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication. Missing values in the treatment phase (i.e., after the baseline phase) were imputed by carrying forward the preceding values in the same phase. | Posted | Number | Participants | 2 hours after dose |
|
|
|
| Secondary | Functional Status at 2 Hours After Dose | 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). | An "all-patients-treated" approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value. | Posted | Number | Participants | 2 hours after dose |
|
|
|
| Secondary | Nausea at 2 Hours After Dose | Patients who recorded the presence or absence of nausea 2 hours after dose | An "all-patients-treated" approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value. | Posted | Number | participants | 2 hours after dose |
|
|
|
| 1 |
| 164 |
| 62 |
| 164 |
| EG001 | Rizatriptan 10 mg | Rizatriptan 10 mg orally once for treatment of single migraine attack | 0 | 387 | 159 | 387 |
| EG002 | Sumatriptan 100 mg | Sumatriptan 100 mg orally once for treatment of single migraine attack | 0 | 388 | 188 | 388 |
| EG003 | Placebo | Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack | 0 | 160 | 51 | 160 |
| Chills | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Cold Sensation | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Fever | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Pain, Abdominal | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Pain, Chest | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Warm Sensation | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Palpitation | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Acid Regurgitation | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Alkaline Phosphatase Increased | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Alanine Aminotransferase Increased | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Aspartate Aminotransferase Increased | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Heaviness, Regional | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Pain, Neck | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Pain, Shoulder | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Stiffness | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Hypesthesia | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Somnolence | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Discomfort, Pharyngeal | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Flushing | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Sweating | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Blurred Vision | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Perversion, Taste | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Hot Flashes | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Urinary Frequency | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D009422 | Nervous System Diseases |
| Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Pain relief did not occur within 2 hrs |
|
| No 2-hour pain freedom |
|
| Mildly impaired |
|
| Severely impaired |
|
| Required bed rest |
|
| No 2-hour Nausea |
|