EUCTR2015-005086-23-SE进行中（未招募）1 期
Mekobalamin's (Vitamin B12) effect on long-term pain in women with fibromyalgi.
innéuniversitetet0 个研究点目标入组 40 人开始时间: 2018年4月20日最近更新:
适应症
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
- 40
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
- Female
入选标准
- •*Swedish speaking women between 20-70 years
- •*Diagnosed with fibromyalgia
- •*Conscent to the trial
- •* Use a safe birth control method such as birth control pills, p-rod, p-syringe, p-patch, hormone coil, copper coil
- •*-Renal function value
- •GFR >60 mL/min/1,73 m2
- •*Liver function value:
- •P-ALP 0,6-2,85 µkat/L
- •P-ALAT 0,15-1,13 µkat/L
- •*Cardiac function value
- •Troponin-T < 15 ng/L
- •NT-pro-BNP >125 <450 <50 years
- •NT-pro-BNP >300 <900 50-75 years
- •*Kobalamin >250 pmol/L < 800 pmol/L
- •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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •*use of neuroleptics (antipsychotic treatment)
- •*have Reynaud's phenomenon (white finger)
- •* neuropathi (numbness)
- •*previous treatment with Vitamin B12
- •*cardiac, hepatic or renal impairment
- •*hypersensitivity to the active substance or any of the excipients
- •*pregnant or planning to become pregnant
- •*breast feeding
研究者
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