Single Center, Open-Label, Prospective Study for Evaluation of Dosulepin Hydrochloride in the Management of Chronic Pain.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- The primary objective of the study is to show that there will be change in pain score from baseline till end of therapy at three months evaluated by a 11 point Numerical Rating Scale (NRS). This is tested using a two sided paired t-test where the 11 point NRS values are measured at baseline and the end of the study (or the last value measured score). A 95% confidence interval for mean change in 11 point NRS scores pre and post treatment will be calculated.
研究概览
简要总结
Chronic pain is a major public health problem that places serious stress on afflicted individuals, the health care system and private industry. It has been associated with deficits in quality of life and psychological adjustment, disability, reduced income potential, high levels of health care utilization and high costs to private industry. International Association for the Study of Pain1 defines Chronic Pain as pain without apparent biological value that has persisted beyond the normal tissue healing time (usually taken to be 3 months). Chronic pain affects individuals of all ages and ethnic backgrounds as well as both sexes.
The most common causes of Chronic Pain include but are not limited to backache headaches and migraines, cancer, degenerative conditions, trigeminal neuralgia, fibromyalgia.
The type of chronic pain include:
Mild to severe pain that does not go away
Pain that may be described as shooting, burning, aching, or electrical
Feeling of discomfort, soreness, tightness, or stiffness
More often, pain is not a symptom that exists alone. Other problems associated with pain include:
Fatigue
Sleeplessness
Withdrawal from activity and increased need to rest
Weakened immune system
Changes in mood including hopelessness, fear, depression, irritability, anxiety, and stress
Disability
CHRONIC PAIN prevalence estimates reported in various international studies range from 10.1% to 55.2%.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
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.
结局指标
主要结局
The primary objective of the study is to show that there will be change in pain score from baseline till end of therapy at three months evaluated by a 11 point Numerical Rating Scale (NRS). This is tested using a two sided paired t-test where the 11 point NRS values are measured at baseline and the end of the study (or the last value measured score). A 95% confidence interval for mean change in 11 point NRS scores pre and post treatment will be calculated.
时间窗: Three Months
次要结局
- Analysis of Secondary Endpoints:(1.Quality of life assessed by change in score from baseline of American Chronic Pain Association-Quality of Life Questionnaire)