CTRI/2010/091/000425已完成3 期
A MULTICENTRE, OPEN-LABEL, ACTIVE-CONTROLLED, COMPARATIVE, RANDOMISED, PARALLEL-GROUP CLINICAL TRIAL OF ELETRIPTAN ORAL TABLET FORMULATION IN ADULT MIGRAINE PATIENTS ACROSS THREE ATTACKS
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1)Male and female adult patients aged 18 to 65 years and having the diagnosis of migraine with or without aura according to International Headache Society criteria
- •2)May or may not be taking prophylactic treatments for migraine
- •3)Frequency of migraine episodes is 1 to 6 per month
- •4)Minimum duration of the illness is 1 year
- •5)Migraine onset is before the age of 50 years
- •6)Female patients who meet the above criteria must also meet the following additional criteria:
- •- Post-menopausal
- •- If of child-bearing potential, must be using medically acceptable contraception, and must consent to use barrier method of contraception before entry and throughout the study, or are surgically sterilised, or has a male partner who has undergone sterilization
- •- Must have a negative result of serum pregnancy test at screening
- •7)Subjects fulfilling the above criteria and who are willing to provide their informed consent, indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- •8)Subjects must be willing to fill-up the migraine diary (provided to them) during each migraine attack and up to three times that they may suffer over the study period
- •9)Subjects must be compliant with self-administration of medication.
排除标准
- •A patient is excluded from the study if he or she meets any of the following criteria:
- •1)Atypical migraine that has consistently failed to respond to migraine therapy
- •2)Concomitant frequent non-migrainous headache (e. g., more than 6 attacks per month on average)
- •3)Presence of migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, or migrainous infarction
- •4)Any acute or unstable medical condition
- •5)Conditions associated with severely limited gastrointestinal absorption
- •6)Any medical condition (including documented hypersensitivity) that contraindicates the use of triptan drugs
- •7)Use of drugs that can interact with the triptans
- •8)History of misuse of analgesic drugs (defined as use of >50 g of aspirin or >100 tablets of analgesics in one week) or ergotamine (defined as use on >2 days per week)
- •9)Misuse or abuse of alcohol or other substances, based on the Diagnostic and Statistical Manual of Mental Disorders Version IV (DSM-IV) criteria
- •10)Clinically significant abnormal laboratory test values at baseline
- •11)Subjects whose baseline electrocardiogram (ECG) has been reported other than "within normal limits"
- •12)Use of investigational drugs within 1 month prior to screening
- •13)Unable or unwilling to provide written informed consent
- •14)Not willing to fill-up the migraine diary during an episode of migraine
- •15) Pregnant women and lactating mothers
- •16)Women of child-bearing potential not taking effective contraceptive precaution
- •17)Women of child-bearing potential not consenting to use barrier contraceptives
- •18)Have a history of repeated non-compliance with treatment
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