EUCTR2016-003146-89-GB进行中（未招募）1 期
A multicentre, double-blind, centre-stratified, multi-period crossover trial to evaluate the efficacy of the Optimal Pathway for TreatIng neurOpathic paiN in Diabetes Mellitus (OPTION-DM). - OPTION-DM
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 392
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. Participant aged =18 years
- •2. Neuropathic pain affecting both feet for at least 3 months or taking pain medication for neuropathic pain for at least 3 months
- •3. Bilateral distal symmetrical neuropathic pain confirmed by the Douleur Neuropathique 4 (DN4) questionnaire at screening visit (52)
- •4. Bilateral distal symmetrical polyneuropathy confirmed by modified Toronto Clinical Neuropathy Score (mTCNS) > 5 at screening visit (53)
- •5. Stable glycaemic control (HbA1c < 108mmol/mol)
- •6. Participants will have a mean total pain intensity of at least 4 on an 11-point numeric rating scale (NRS; with 0 being ‘no pain’ and 10 ‘worst pain imaginable’) during 1 week off pain medications (Baseline Period)
- •7. Willing and able to comply with all the study requirements and be available for the duration of the study. This will be a 1 year study in which all participants will undergo all Treatment Pathways regardless of treatment response and this point will be made clear
- •8. Willing to discontinue current neuropathic pain relieving medications
- •9. Informed consent form for study participation signed by participant
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 294
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 98
排除标准
- •1. Non-diabetic neuropathies
- •2. History of alcohol/substance abuse which would, in the opinion of the investigator, impair their ability to take part in the study
- •3. History of severe psychiatric illnesses which would, in the opinion of the investigator, impair their ability to take part in the study
- •4. History of epilepsy
- •5. Contraindications to study medications
- •6. Pregnancy/breast feeding or planning pregnancy during the course of the study
- •7. Use of prohibited concomitant treatment (as detailed in section 8.10) that could not be discontinued
- •8. Use of high dose morphine equivalent (>100mg/day)
- •9. Liver disease (LFTs >2 times upper limit of normal)
- •10. Significant renal impairment (eGFR <30mL/minute/1.73m2)
- •11. Heart failure New York Heart Association (NYHA) = class II
- •12. Clinically significant cardiac arrhythmias on 12 lead ECG
- •13. Patients with a recent myocardial infarction (<6 months prior to randomisation)
- •14. Postural hypotension (reduction of > 20mmHg)
- •15. Prostatic hypertrophy or urinary retention to an extent which would, in the opinion of the investigator, be a contraindication to the study medication
- •16. Patients with other painful medical conditions where the intensity of the pain is significantly more severe than their diabetic peripheral neuropathic pain (patients will not be excluded if the pain is transient in nature)
- •17. Any suicide risk as judged by the investigator or as defined by a score of =2 on the suicide risk questionnaire
- •18. Significant language barriers which are likely to affect the participants understanding of the medication schedule or ability to complete outcome questionnaires
- •19. Concurrent participation in another clinical trial of an investigational medicinal product
- •20. Major amputations of the lower limbs
- •21. Active diabetic foot ulcers
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