EUCTR2015-004779-64-FR进行中（未招募）1 期
Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) for the Treatment of Peripheral Neuropathic Pain: a Randomised, International, Multicentre, Placebo-Controlled, Phenotype-stratified Phase IIa Study
Air Liquide Santé International0 个研究点目标入组 287 人开始时间: 2016年10月27日最近更新:
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
- 287
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
- •-Male or female patient aged 18 years or older
- •-Definite or probable peripheral neuropathy confirmed by DN4 (score = 4) and NeuPSIG criteria (definite” or probable” levels) (see Appendix 2 and 3)
- •-Neuropathic pain lasting for more than 3 months but less than 10 years
- •-Pain intensity = 4 but = 9 as assessed on the 11-point NRS (Numeric Rating Scale)
- •-Stable analgesic medications since at least 4 weeks prior the Selection visit V0
- •-Peripheral neuropathy with at least one of the following aetiologies :
- •Post-traumatic or post-surgical nerve injury
- •Polyneuropathy including diabetic neuropathy
- •Post-herpetic neuralgia
- •-Patient willing and able to complete the requirements of this study
- •-Written informed consent signed and dated by the patient after full explanation of the study prior to any study related procedures
- •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 350
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 350
排除标准
- •-Legal incapacity or limited legal capacity
- •-Patient with another concomitant chronic pain
- •-Ongoing major depression
- •-Patient with ongoing litigation
- •-Pregnancy or lactation
- •-Severe terminal illness
- •-Anticipated difficulties for administration of inhaled gas by mask (facial deformation that would make mask administration of inhaled gases inefficient)
- •-Risk of need for high inhaled oxygen concentrations
- •-Chronic respiratory failure requiring regular oxygen therapy
- •-Ketamine administered within one week before selection
- •-Hypnosis sessions (including self-hypnosis) or any other complementary medicine treatment planned during the study
- •-Participation in a drug or device trial within the previous 30 days
- •-Known contraindication to administration of Nitrous Oxide/Oxygen 50%/50% (EMONO) including documented and untreated vitamin B12 or folic acid deficiency
研究者
相似试验
进行中（未招募）
1 期
Treatment of Peripheral Neuropathic PaiEUCTR2015-004779-64-DEAir Liquide Santé International287
已完成
不适用
Impact of a nitrous oxide / oxygen mixture (LIVOPAN) on pain intensity during photodynamic therapy – an observational study (LIVOPAN-trial)Actinic keratosisR52.0L57.0Acute painDRKS00006054niversitätsklinikum Heidelberg71
已完成
2 期
EMONO for the Treatment of Peripheral Neuropathic PainNeuralgiaNCT02957851Air Liquide Santé International287
Unknown
不适用
The efficacy of 50% Nitrous Oxide mixture (Entonox) for Pain Relief during Perineorrhaphy : A Randomized Controlled TrialPregnant women after vaginal delivery with 2nd or 3rd degree perineal tear and requires perineorrhaphy.perineorrhaphyEntonox50% nitrous oxideVaginal deliveryperineal tearTCTR20220503006Faculty of Medicine Siriraj Hospital84
已完成
2 期
The effect of Nitrous Oxide in comparison to Oxygen combined with Fentanyl on the staying time and pain reduction in renal colic patients at Emergency roomrenal colic.Unspecified renal colicIRCT2013020512369N1Vice chancellor for research, Isfahan University of Medical Sciences120