IM Ketorolac vs Diclofenac Potassium Powder for Oral Solution (Cambia) for the Acute Treatment of Severe Migraine
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain relief, 0-3 scale
研究概览
简要总结
This research will be conducted to see if the oral drug Cambia is as effective in relieving severe migraine headaches as the injectable drug ketorolac.
详细描述
The treatment of severe migraine often requires a patient office visit or treatment in the ER or urgent care setting. This is due to the minimal efficacy of PO treatments once migraine is severe, and therefore the need for parenteral treatments. IM Ketorolac is one mainstay of parenteral treatment. There is an unmet need for effective at-home treatment regimens for severe migraine. Despite FDA approval of Cambia for acute migraine treatment, insurance is reticent to cover the treatment due to higher cost in comparison to generic diclofenac tablets, despite superior efficacy of Cambia in comparison to generic diclofenac tablets (Diener, Cephalalgia 2006). One objective of this study would be to provide rationale to justify the insurance coverage of this treatment in comparison to generic tablets, because at home treatment is less costly than office visit or emergency department visit to receive IM ketorolac.
A previous study of Cambia demonstrated that this formulation of diclofenac potassium for oral solution is effective in reducing pain intensity within 30 minutes, which may be related to the 15-minute Tmax associated with this formulation. The rapid-onset benefits were sustained through 24 hours post-treatment (Lipton, Cephalalgia 2010)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet IHS criteria for migraine
- •Age 18 to 65
- •At least 2 migraine attacks per month
- •Able to give written consent
- •Willing to complete the entire course of the study
- •Current headache duration greater than or equal to 36 hours
排除标准
- •Pregnant or nursing
- •Significant medical or psychiatric disease
- •History of gastritis, gastric ulcer, GI bleed
- •Renal insufficiency
- •Hepatic insufficiency
- •History of opioid dependence within the last 10 years or currently
- •Any current or prior use of DICLOFENAC POTASSIUM POWDER FOR ORAL SOLUTION (CAMBIA)
- •Past allergic reaction to DICLOFENAC or other NSAIDs
研究组 & 干预措施
Cambia
Diclofenac postassium powder for oral solution and placebo injection
干预措施: Diclofenac postassium powder for oral solution and placebo injection (Drug)
ketorolac
ketorolac intramuscular injection and placebo oral solution
干预措施: Ketorolac intramuscular injection and placebo oral solution (Drug)
结局指标
主要结局
Pain relief, 0-3 scale
时间窗: Change from baseline pain rating at 5, 10, 15, 30, and 60 minutes post intervention
Pain free response, 0-3 scale
时间窗: 2 hours post intervention
Sustained pain free response, 0-3 scale
时间窗: 24 hours post intervention
次要结局
- Change in severity of migraine associated symptoms(5, 10, 15, 30, 60, 120 minutes and 24 hours post intervention)
- Return to function(24 hours post intervention)
研究者
Emily Rubenstein Engel
Associate Director, Dalessio Headache Center, Scripps Clinic
Scripps Health