EUCTR2011-004371-36-ES进行中（未招募）不适用
Effects of pregabalin on slow wave sleep and glucose tolerance in patients with diabetic polyneuropathy. An exploratory study. - NA
Instituto de Investigaciones del Sueño0 个研究点目标入组 0 人开始时间: 2011年11月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- 性别
- All
入选标准
- •1.History of signs and symptoms of bilateral painful DPN (confirmed by means of a nerve conduction study).
- •2.Beginning of the sensory symptoms symmetrically in both feet.
- •3.If symptoms of DPN are in remission because of being currently controlled with medication, history of signs and symptoms of diabetic neuropathy.
- •4.If the patient presents symptoms at the moment of the study inclusion, these symptoms must interfere with sleep onset or sleep maintenance during an average of at least four nights per week for the last three months.
- •5.Type II diabetes with HbA1c?10
- •6.Duration of DPN ?6 months.
- •7.A score of >40 mm on the Short-Form McGill Pain Questionnaire (SF-MPQ) visual analogue scale (VAS).
- •8.A score ?4 on a VAS pain rating scale, based on at least 4 daily pain entries during the week before randomization.
- •9.WASO <60% as completed on a sleep diary.
- •10.If the patient is taking anti-diabetic medication at the moment of study inclusion, the patient must have been on a stable regimen for 30 days previous to randomization.
- •11.Patients who are willing and able to comply with the patient sleep diary, scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •12.Patients who accept that they might be treated with placebo during the first study phase.
- •13.Patients aged between 18 and 80 years.
- •14.Women of childbearing potential must have a negative pregnancy test at screen and must agree not to become pregnant.
- •15.Prior to any study specific procedures, the patient must personally sign and date the informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1.History of diseases (pernicious anemia, hypothyroidism, etc.) that occur with sensory neuropathy.
- •2.History or current diagnosis of other clinically relevant diseases that may confound assessments of DPN symptoms.
- •3.Patients who require current prescription medication for concomitant diseases which could interfere with efficacy assessments.
- •4.Diagnosis of significant physical or psychiatric disorder (such as symptomatic peripheral vascular disease).
- •5.History of exposition to substances known to cause neuropathy or that are potential retinotoxins.
- •6.Sleep apnea with an index of apneas and/or hypoapneas per hour of sleep > 20.
- •7.Employed in shift work (for example, employment hours disruptive to the normal circadian sleep-wake cycle such as nighttime or variable rotating shifts) or irregular sleep-wake schedules.
- •8.Surgery within the previous 180 days of baseline visit, which in the opinion of the investigator would negatively impact the patient?s participation in the study.
- •9.Any other clinically significant condition or laboratory assay abnormality, which could interfere with the patient?s ability to participate in the study.
- •10.Pregnant or lactating women.
- •11.Patients with known hypersensitivity and/or intolerance to any component of the study drug or similar drugs.
- •12.Clinically significant renal disease which could cause that the patient might not complete the study, or an increase of serum creatinine 1.5 times higher than the upper limit of normal laboratory ranges. Abnormal results of analysis implying that a patient can not be included in the study can be repeated once, before the basal visit, with the aim to confirm or reject patient inclusion.
- •13.Patients who had participated in other investigational drug studies or who had received other investigational drugs within the previous 30 days of the selection visit.
- •14.History of chronic alcoholism or drug abuse during the last 12 months.
研究者
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