NCT01228552Unknown3 期
A Randomized Double Blind, Placebo Controlled Phase III Trial to Determine the Efficacy and Safety of Topical Intra-oral Ketoprofen for the Treatment of Acute Migraine
Behar, Caren, M.D.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain relief (defined as at least 2 graded reduction in a 5-grade scale) at 120 minutes post-treatment
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of intra-oral topical ketoprofen for the treatment of acute migraine.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Established diagnosis of Migraine as per IHS with aura
- •Established diagnosis of Migraine as per IHS without aura
- •At least 2 migraines per month
- •At least 18 years of age
排除标准
- •Pregnancy or Lactation
- •Other Headache Conditions including basilar, hemiplegic, or ophthalmoplegic migraines
- •Chronic Daily Headache
- •Allergy or Sensitivity to NSAIDs
- •Other Severe Medical Conditions including GI bleeding, blood dyscrasias, thrombocytopenia
研究组 & 干预措施
Topical, intra-oral ketoprofen gel
Active Comparator
干预措施: Topical, intra-oral ketoprofen gel (Drug)
Placebo gel
Placebo Comparator
干预措施: Placebo gel (Other)
结局指标
主要结局
Pain relief (defined as at least 2 graded reduction in a 5-grade scale) at 120 minutes post-treatment
时间窗: Within 240 minutes post-treatment
次要结局
- Pain relief at 30, 60, and 240 minutes post-treatment based on headache severities reported in patient's journals(Within 240 minutes post-treatment)
- Relief of Photophobia at 30, 60, 120, and 240 minutes post-treatment(Within 240 minutes post-treatment)
- Pain free status at 30, 60, 120, and 240 minutes post-treatment based on headache severities reported in patient's journals(Within 240 minutes post-treatment)
- Relief of Phonophobia at 30, 60, 120, and 240 minutes post-treatment(Within 240 minutes post-treatment)
- Relief of Nausea at 30, 60, 120 and 240 minutes post-treatment(Within 240 minutes post-treatment)
- Relief of Vomiting 30, 60, 120 and 240 minutes post-treatment(Within 240 minutes post-treatment)
- Need for Rescue Medication between the time of dosing to 240 minutes(Within 240 minutes post-treatment)
研究者
研究点 (1)
Loading locations...
相似试验
终止
3 期
Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or BursitisTendonitisBursitisNCT00426985APR Applied Pharma Research s.a.381
已完成
3 期
Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or BursitisTendonitisBursitisNCT00352625APR Applied Pharma Research s.a.330
已完成
3 期
Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Ankle Sprain or StrainStrainSprainNCT00351104APR Applied Pharma Research s.a.200
已完成
2 期
Ketoprofen in Transfersome Compared to Oral Celecoxib and Placebo for Pain Associated With Osteoarthritis of the KneeOsteoarthritis, KneeNCT00317733IDEA AG360
已完成
3 期
HKT-500 in Adult Patients With Osteoarthritis (OA) Knee PainOsteoarthritis of the KneeNCT00792727Hisamitsu Pharmaceutical Co., Inc.380