NCT00510419已完成3 期
A Phase 3 Open-Label Study to Assess Subcutaneous Self-Injection With Sumatriptan Succinate Using an Auto-injector During a Single Migraine Attack
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 73
- 试验地点
- 20
- 主要终点
- Successful administration and acceptability of self-injection of sumatriptan under the skin using an investigational auto-injector will be assessed by use of patient-completed scales and a short questionnaire.
研究概览
简要总结
The purpose of this research study is to evaluate an investigational auto-injector system for delivering sumatriptan under the skin for a single migraine attack.
The study could take approximately 5 weeks and will include about 3 office visits to the study doctor, the patient will be contacted every 2 weeks until the patient experiences a migraine and uses the auto-injector. The last visit will be done by a telephone follow-up call.
详细描述
Investigational Plan:
- Screening Visit [Visit 0 / 0-14 days prior to receipt of study drug]
- Baseline Visit [Visit 1 / Provision of study drug and subject training]
- Treatment Visit [Visit 2 / within 72 hours after study drug administration]
- Follow-up Visit [Visit 3 / Telephone follow-up 7-10 days after study drug administration]
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 to 60 years of age
- •Prior effective use of injectable sumatriptan on at least two occasions within the last two months
- •At least two migraines per month suitable injectable sumatriptan
- •Capable of using a migraine self-injection auto-injector
- •Capable of distinguishing between migraine and other headache types (e.g., tension-type headache)
排除标准
- •Seizure disorders
- •Coronary artery disease (CAD)
- •Cardiac dysrhythmia or pacemaker
- •High blood pressure
- •Liver disease
- •Kidney disease
- •Autoimmune disease
- •History of alcohol or substance abuse
- •Currently pregnant
- •Use of any other investigational drug product within 30 days prior to treatment visit
结局指标
主要结局
Successful administration and acceptability of self-injection of sumatriptan under the skin using an investigational auto-injector will be assessed by use of patient-completed scales and a short questionnaire.
次要结局
- • Comparison of pain scores pre-dose and 2 hours post-dose. • Preference of investigational auto-injector experience compared to subject's previous self-administration of sumatriptan.
研究者
研究点 (20)
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