CTRI/2013/10/004071已完成4 期
A prospective, open-label, multicentre, non-comparative, post marketing observational study evaluating effectiveness and tolerability of Carbamazepine (TEgrital®) As Monotherapy in treatment naïve patients with generalized tonic-clonic seizures in routine clinical practice in India. - TEAM study
ovartis India Limited0 个研究点目标入组 493 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 493
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1.Male and female out patients > 1 year to < 60 years of age with diagnosis of generalized tonic-clonic seizures that have been prescribed Carbamazepine as monotherapy (in OAED naïve patients) as per local prescribing information.
- •2.Patients or their parent/legally-authorized guardian having given written, informed consent and/or assent to have their data collected after the nature of the trial had been fully explained (according to the local legal regulatory requirements). Patients will not need to consent for taking the drug, as their treatment is decided before entry into the study and is part of their medical care.
- •3.Patients who agree to follow medication as per local prescribing information of the study drug while participating in the study.
排除标准
- •Patients who meet any of the following criteria are not eligible for inclusion in this study:
- •1.Patients with absence seizure or with juvenile myoclonic seizure.
- •2.Patients who require two or more anti-epileptic drug.
- •3.Patients with any psychiatric coexistent illness that may affect the patientâ??s compliance with study procedures.
- •4.Known hypersensitivity to the study drug, excipients or to drugs of similar chemical classes.
- •5.Pregnant or nursing (lactating) women.
- •6.Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method (if accepted by local ethics committee) or a barrier method plus a hormonal method.
- •Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.
- •Reliable contraception should be maintained throughout the study and for 7 days after the study.
- •Woman are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels 40 mIU/ml [for US only: and estradiol 20 pg/ml] or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.
- •7.Any other contra-indication according to local prescribing information for study drug.
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