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The study evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.
Evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Intranasal Placebo |
|
| Ketorolac tromethamine | Experimental | Intranasal ketorolac tromethamine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac tromethamine | Drug | 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point. | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | 2 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | 0.5 hours post-dosing |
| The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger Whiting, Ph D | American Regent, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Volker Pfaffenrath | Munich | Bavaria | 80802 | Germany |
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5 months and 3 weeks; Medical Centers and Hospitals
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketorolac Tromethamine | Intranasal ketorolac tromethamine Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride) |
| FG001 | Placebo | Intranasal Placebo Placebo : Intranasal (IN) placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketorolac Tromethamine | Intranasal ketorolac tromethamine Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride) |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point. | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | Modified ITT | Posted | Number | participants | 2 hours after dosing |
|
5 months and 3 weeks
ITT population
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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 | Ketorolac Tromethamine | Intranasal ketorolac tromethamine Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoaesthesia | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Bregman, M.D., Ph.D | Luitpold Pharmaceuticals, Inc. | 601-650-4200 | 828 | dbregman@lpicrd.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 |
|---|---|
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo | Drug | Intranasal (IN) placebo |
|
Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain |
| 1 hour post-dosing |
| The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | 1.5 hours post-dosing |
| The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | 3 hours post-dosing |
| The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | 4 hours post-dosing |
| The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | 24 hours post-dosing |
| The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | 48 hours post-dosing |
| No treatment for migraine |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
Intranasal Placebo
Placebo : Intranasal (IN) placebo
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | Modified ITT | Posted | Number | participants | 0.5 hours post-dosing |
|
|
|
| Secondary | The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | Modified ITT | Posted | Number | participants | 1 hour post-dosing |
|
|
|
| Secondary | The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | Modified ITT | Posted | Number | participants | 1.5 hours post-dosing |
|
|
|
| Secondary | The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | Modified ITT | Posted | Number | participants | 3 hours post-dosing |
|
|
|
| Secondary | The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | Modified ITT | Posted | Number | participants | 4 hours post-dosing |
|
|
|
| Secondary | The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | Modified ITT | Posted | Number | participants | 24 hours post-dosing |
|
|
|
| Secondary | The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain | Modified ITT | Posted | Number | participants | 48 hours post-dosing |
|
|
|
| 1 |
| 69 |
| 53 |
| 69 |
| EG001 | Placebo | Intranasal Placebo Placebo : Intranasal (IN) placebo | 0 | 73 | 40 | 73 |
| Fatigue | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Intranasal hypoaesthesia | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Pharyngeal hypoaesthesia | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D006571 | Heterocyclic Compounds |