CTRI/2011/12/002207招募中4 期
Single Center, Open-Label, Prospective Study for Evaluation of Dosulepin Hydrochloride in the Management of Chronic Pain. - NI
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 63
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
- •Adult male and female patients aged 18-65 years, suffering from non-neoplastic chronic pain persisting for more than three months.
排除标准
- •Main Exclusion Criteria:
- •1.Patients with a history of acute chest pain or myocardial infarction in the previous 3 months. Patients with cardiac conduction defects or disorders of cardiac rhythms.
- •2.Patients with history of severe pulmonary disease with symptoms of severe breathlessness at rest, chronic cough or wheezing.
- •3.Patients with severe liver disease (Liver function tests ¡Ý 3 times the upper limit of normal) or history of acute abdominal pain, colicky gastrointestinal pain in the last 3 months.
- •4.Patients with a history of prostatic hypertrophy or those undergoing elective surgery.
- •5.Patients with history of epilepsy, dementia, or encephalopathy.
- •6.Patients with a history of narrow angle glaucoma and/or disturbances in visual acuity.
- •7.Patients with a history of substance abuse or an allergic reaction to an opioid or a TCA.
- •8.Patients with a history of mania or suicidal tendencies.
- •9.Patients being treated with thyroid hormone or those suffering from hyperthyroidism.
- •10.Pregnant or lactating women and female patients not willing to use adequate birth control measures, from the time of screening until the completion of the study.
- •11.Patients on MAO inhibitors, barbiturates, local anesthetics containing adrenaline (epinephrine) or noradrenaline (norepinephrine), quinidine, SSRIs, CNS depressants, anaesthetic drugs, drugs which affect cardiac conduction, methylphenidate and who cannot be withdrawn, will be excluded.(Refer Appendix C for complete list).
- •12.Patients with history of hypersensitivity to Dosulepin or any of its ingredients.
- •13.Subjects who have used any investigational product within 30 days prior to the screening visit.
- •These exclusion criteria are adequate to identify and exclude patients of chronic pain who may be harmed if included in the study.
研究者
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