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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_081 |
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Study to test the effectiveness of a marketed drug in the treatment of migraine-associated nausea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Rizatriptan (MK0462)10 mg orally disintegrating tablet/oral lyophilisate |
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| 2 | Placebo Comparator | matching placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: Rizatriptan | Drug | One dose Rizatriptan 10 mg orally disintegrating tablet / oral lyophilisate to treat one migraine attack. |
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| Measure | Description | Time Frame |
|---|---|---|
| Participants With Elimination of Nausea at 2 Hours Postdose | Participants reporting the absence of nausea at 2 hours post treatment. Absence or presence of nausea was recorded by the participants in an electronic diary. Absence is defined as no nausea at 2 hours post-treatment. | At 2 hours after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Pain Relief at 2 Hours Postdose | Participants reporting pain relief defined as a reduction of pain 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 treatment |
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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 |
|---|---|---|---|
| 18047500 | Background | Freitag F, Taylor FR, Hamid MA, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Elimination of migraine-associated nausea in patients treated with rizatriptan orally disintegrating tablet (ODT): a randomized, double-blind, placebo-controlled study. Headache. 2008 Mar;48(3):368-77. doi: 10.1111/j.1526-4610.2007.00954.x. Epub 2007 Nov 28. |
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Each patient was to treat one migraine attack of moderate or severe intensity with accompanying nausea. Rescue medication was allowed for headache non-response or recurrence after 2 hours postdose. Patients were to treat a qualifying migraine attack within 3 months after randomization.
Twenty-Four (24) investigators in the United States
Primary Therapy Period: MAR06 to OCT06.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rizatriptan 10 mg | Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack |
| FG001 | Placebo | Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rizatriptan 10 mg | Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack |
| BG001 | Placebo | Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Participants With Elimination of Nausea at 2 Hours Postdose | Participants reporting the absence of nausea at 2 hours post treatment. Absence or presence of nausea was recorded by the participants in an electronic diary. Absence is defined as no nausea at 2 hours post-treatment. | Full Analysis Set (FAS): The FAS population included all randomized and treated Participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment). | Posted | Number | Participants | At 2 hours after treatment |
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Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy.
Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.
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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 10 mg | Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 9.1 | 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 |
| 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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| Comparator: Placebo | Drug | One dose matching placebo to Rizatriptan to treat one migraine attack. |
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| Withdrawal by Subject |
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| Lack of Migraine Attack |
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| Qualifying migraine but did not treat |
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| Other |
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| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
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| Secondary | Participants With Pain Relief at 2 Hours Postdose | Participants reporting pain relief defined as a reduction of pain 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. | Full Analysis Set (FAS): The FAS population included all randomized and treated Participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment). | Posted | Number | Participants | 2 hours after treatment |
|
|
|
| 0 |
| 200 |
| 30 |
| 200 |
| EG001 | Placebo | Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack | 0 | 97 | 4 | 97 |
| Vision blurred | Eye disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Lip swelling | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Paraesthesia oral | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Peripheral coldness | General disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
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| Muscle fatigue | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Dissociative disorder | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Euphoric mood | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Pharyngeal hypoaesthesia | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
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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 |