Fibromyalgia and Naltrexone: The FINAL study - FINA

Odense University Hospital0 个研究点目标入组 99 人开始时间: 2019年8月23日最近更新: 2024年2月19日

适应症

试验速览

暂无简介。

•-Women aged 18-64 years
•-Understands and writes Danish
•-Fulfills the ACR1990 criteria for fibromyalgia
•-A minimum score of 4 in self-reported average pain during the last 7 days on a 0-10 NRS at baseline
•-All fertile women have to use safe anti conception
•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 100
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•-Known allergy against naltrexonehydroclorid
•-Pregnancy or breastfeeding. A negative pregnancy test has to be available for all fertile subjects at baseline
•-Use of opioids or NSAIDs up to 4 weeks before inclusion in the trial
•-Abuse of alcohol or other substances
•-Inflammatory rheumatic diseases
•-Demyelinating diseases
•-Active cancer
•-Liver dysfunction (ALAT must not be elevated more than 2-fold over highest reference level)
•-Kidney dysfunction (GFR < 59 mL/min)
•-Psychotic diseases
•-History of suicide attempts
•-Suicide ideation – evaluated using PHQ-9 (Item 9 has to be answered never”)

发起方