EUCTR2007-006184-70-GB进行中（未招募）1 期
A POPULATION STUDY INTO THE PREVALENCE AND GENETIC PROFILE OF PATIENTS WITH CHRONIC PAIN WHO DO NOT RESPOND TO ORAL CODEINE A single site, pilot population study into the prevalence and genetic profile of patients with chronic pain who do not respond to oral codeine. - Codeine Non responders study
The Leeds Teaching Hospitals NHS Trust0 个研究点目标入组 150 人开始时间: 2009年1月20日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •I.Male or female Caucasian subjects, ages between 18-80 years.
- •II.Signed and dated written informed consent.
- •III.Females of childbearing potential must have a negative pregnancy test and be practicing an effective form of contraception.
- •IV.Patients with a chronic pain condition >3 months duration that has been diagnosed by a pain management specialist.
- •V.Patients with moderate to severe chronic pain (defined as a score of 4 (out of 10) or above on worst pain in the last 24 hours (question 3) on the Brief Pain Inventory at screening and daily in the Patient Diary during pre-treatment.)
- •VI.Adequate renal function (serum creatinine females <130 ?mol/l: males <150 ?mol/l).
- •VII.Liver enzymes (AST or ALT) less than twice the upper limit of normal. Alkaline phosphates less than twice the upper limit of normal.
- •VIII.Bilirubin within the normal range, or abnormalities clinically insignificant in the judgment of the investigator.
- •IX.Deemed capable of complying with study schedule, procedures and medications
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •I.Patients with a known sensitivity to codeine or who have a history of experiencing intolerable opioid analgesic side effects.
- •II.Patients whose pain could be adequately controlled by increasing their dose of weak opioids.
- •III.Patients with a history of recreational drug use within the last 2 years.
- •IV.Patients with a history of alcohol abuse within the last 2 years.
- •V.Female patients who are pregnant, lactating or of child bearing potential who are not taking adequate contraceptive precautions i.e. an oral contraceptive, an approved hormonal implant, an intrauterine device or condoms/diaphragm and spermicide). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy).
- •VI.Abnormal serum electrolytes, which in the investigators opinion would exclude the patient from this study
- •VII.Abnormal urine analysis, which in the investigators opinion would exclude the patient from this study
- •VIII.Haemoglobin outside the normal limits and white blood cell count below the lower limit of normal or above 12 x 109/l.
- •IX.Concurrent surgery, radiotherapy, chemotherapy or nerve blocks and those who have received this treatment 4 weeks prior to the study.
- •X.Patients taking drugs known to be inhibitors of the cytochrome P450 isozyme 2D6 (Appendix 17.4).
- •XI.Patients taking medications that would interfere with the urinalysis e.g. morphine, hydromorphone.
- •XII.Patients who have anxiety or the depression of a degree that the investigators judge that participation in the study would be detrimental to their mental health.
- •XIII.Patients who are unable to understand and complete assessment questionnaires in English.
- •XIV.Patients who have been in another clinical study within the last 4 weeks
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