EUCTR2007-001431-58-FI进行中（未招募）不适用
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Analgesic Efficacy of Ketorolac Tromethamine Administered Intranasally for the Acute Treatment of Migraine - ROX-2007-01
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Female and male subjects aged 18 to 65 years.
- •2. Diagnosis of migraine with or without aura according to IHS criteria 1.1 and 1.2.1.
- •3. Onset of migraine prior to age 50 years.
- •4. Subjects who have between 2 and 8 moderate or severe migraine headaches per month.
- •5. Ability to communicate well with the study staff and to comply with the requirements of the entire study.
- •6. Subjects who read and understood the patient information sheet and have provided written informed consent to participate in this study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Administration of any investigational drug up to 30 days before study entry or parallel participation in another study.
- •2. Subjects with more than 15 headache days per month.
- •3. Subjects with known allergy to, or known hypersensitivity to ketorolac, lidocaine, EDTA, or tromethamine.
- •4. Subjects with allergic manifestations to aspirin or other NSAIDs or with known history of sensitivity to local anesthetics of the amide type.
- •5. Patients currently receiving aspirin or NSAIDs.
- •6. Subjects who have at screening, as determined by the investigator, abnormal laboratory parameters in particular, liver or renal functions tests greater than twice the upper limit of normal.
- •7. Subjects with advance renal impairment or patients at risk for renal failure due to volume depletion.
- •8. Subjects with a history of a significant medical or psychiatric condition that may affect the safety of the subject or preclude adequate participation in the study.
- •9. Subjects with active peptic ulcer disease or a significant history of peptic ulcer disease or gastrointestinal bleeding.
- •10. Subjects with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and high risk of bleeding.
- •11. Subjects with a history within the last 2 years of abuse of alcohol or prescription or illicit drugs.
- •12. Subjects with any history of cocaine use.
- •13. Subjects who have ever used opiates regularly for any indication and any opiate use in the last 3 months.
- •14. Subjects who are pregnant or breast-feeding. Female subjects who are of child bearing potential must be using highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly (e.g., implants, injectables, combined oral contraceptives in combination with a barrier method, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner).
- •15. Subjects using migraine prophylaxis must have been on stable doses of the prophylactic agent for at least 12 weeks prior to study entry.
- •16. Known Hepatitis B or C or HIV infection.
- •17. Subjects who are employees of the sponsor.
- •18. Subjects who are employees or relatives of the investigator.
研究者
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